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Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

By Carl O’Donnell and Michael Erman



a large building: FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego


© Reuters/MIKE BLAKE
FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are more severely ill and being treated with other drugs as well, including Gilead Sciences Inc’s antiviral remdesivir.

The company had already asked U.S. regulators for an emergency use authorization (EUA) for the antibody drug, called bamlanivimab or LY-CoV555, to treat mild to moderate COVID-19 patients, based on interim data from a different study in those less severe illness. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration did not immediately respond to a request for comment on the status of the EUA application.

LY-CoV555 is similar to the experimental dual-antibody therapy from Regeneron Pharmaceuticals Inc that was used to treat U.S. President Donald Trump. That treatment is also awaiting clearance by U.S. regulators.

Trump touted both drugs as being tantamount to cures in a video he posted last week after being released from the hospital.

Lilly said in a statement that these type of treatments may prove to be less beneficial for hospitalized patients than for those with more mild cases of the disease. A Lilly spokeswoman declined to comment further on why the trial was halted.

The paused trial is being conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH that is working with several drugmakers on COVID-19 treatments and vaccines.

It was halted at the request of an independent oversight panel, called a Data Safety and Monitoring Board (DSMB). It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.

“Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study,” the company said in a statement.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Bill Berkrot)

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Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that vaccine resumed in other regions after a brief halt.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.

It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.

“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.

The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.

Lilly sought the EUA from U.S. regulators after publishing data in September showing LY-CoV555 helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.

Lilly shares closed nearly 3%.

(Reporting by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

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Eli Lilly antibody trial paused over safety concerns

Checking in: The trial design calls for the data and safety monitoring board to examine results from the first 300 participants — including their need for supplemental oxygen, mechanical ventilation or other supportive care five days after receiving the treatment or a placebo — before proceeding with further enrollment.

The NIAID trial has so far enrolled 326 patients. An agency spokesperson said that the board overseeing the trial this morning “reached a predefined boundary for safety at day five.” The board will now decide whether the trial should add 700 more participants.

The NIAID spokesperson added that the pause in enrollment is “out of an abundance of caution” and the safety board is “continuing data collection and follow-up of current participants for safety and efficacy.”

The late-stage study is examining whether Lilly’s antibody, known as bamlanivimab, could help hospitalized patients. The treatment is a monoclonal antibody that mimics the antibodies the body makes naturally. It’s similar to the Regeneron antibody cocktail that President Donald Trump received recently after being diagnosed with Covid-19.

Background: Last week, Lilly asked the FDA to grant an emergency-use authorization that would allow use of the antibody treatment in high-risk patients recently diagnosed with mild-to-moderate Covid-19.

That application is largely based on preliminary data from a Phase II trial released in mid-September that showed patients who received any dose of the antibody were less likely to be hospitalized or visit the ER.

What’s next: The data and safety monitoring board overseeing the trial will review data again at a preplanned meeting on October 26. The board will recommend at that meeting whether or not enrollment should be resumed, according to NIAID.

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FDA faults quality control at Lilly plant making Trump-touted COVID drug

By Dan Levine and Marisa Taylor

(Reuters) – U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” for the disease, according to government documents and three sources familiar with the matter.

The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19.

Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug. The president’s push is key to his efforts to convince voters he has an answer to the pandemic that has killed more than 215,000 Americans.

But the findings by the U.S. Food and Drug Administration inspectors at the Lilly manufacturing facility, which have not been disclosed previously, could complicate the drugmaker’s bid for a so-called emergency use authorization (EUA) from the federal agency, two of the sources and two outside legal experts told Reuters. That’s because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.

The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation.

Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.

“The deleted incidents and related audit trail were not reviewed by the quality unit,” the FDA inspectors wrote. Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.

Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an “Official Action Indicated” (OAI) notice.

That “means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.

Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients “out of an abundance of caution” over a potential safety concern. The company did not release information on what the problem was and declined to say how the news might affect their EUA request.

In response to Reuters’ questions on Monday about the manufacturing issues, Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action. The drugmaker said it has launched a “comprehensive remediation plan,” has increased staffing at the site and was working “aggressively” to address all concerns raised during

U.S. expects over 1 million COVID-19 antibody doses from Regeneron, Lilly in 2020

By Michael Erman and Manas Mishra

NEW YORK (Reuters) – The U.S. government expects to be able to provide at no cost more than 1 million doses of antibody treatments for COVID-19 similar to the one President Donald Trump received to treat his illness, according to a top U.S. health official on Friday.

The government’s Operation Warp Speed program currently has “a couple of hundred thousand doses” of the monoclonal antibody treatments being developed by drugmakers Regeneron Pharmaceutical Inc <REGN.O> and Eli Lilly & Co <LLY.N>, U.S. Department of Health and Human Services official Paul Mango said on a call with reporters. That would top 1 million doses by the end of the year, he said.

Trump received Regeneron’s treatment last week. In a radio interview with Rush Limbaugh on Friday, Trump said he is working to get both drugs approved quickly and that he may not have recovered without the treatments he received.

Both companies have said the drugs were shown to work in clinical trials and that they have submitted an emergency use authorization to the U.S. Food and Drug Administration (FDA).

The drugs are not identical: Regeneron’s treatment is a cocktail of two antibodies meant to protect against the virus, while Lilly’s is a single antibody. Because they have not been tested against the other, it is difficult to know if one is more effective than the other.

It is unclear how long the FDA process to authorize emergency use of the drugs will take. Unless the companies receive that authorization, doctors cannot administer the drugs to patients outside of clinical trials or without a compassionate use authorization like the one President Trump received.

If the drugs are authorized for use by the FDA, Mango said that the government will allocate the treatments to the states based on need, similar to the mechanism used with Gilead Sciences Inc’s <GILD.O> antiviral drug remdesivir for COVID-19.

Regeneron signed a $450 million deal in July to sell Operation Warp Speed enough doses of its antibody treatment, REGN-COV2, to treat around 300,000 people.

The company said it has not signed any additional deals with Operation Warp Speed, and has around 50,000 doses of its treatment ready now.

Lilly said on Friday it has not signed an agreement with Operation Warp Speed. It said earlier this week that it expects to produce around one million doses of the treatment this year.

(Reporting by Manas Mishra in Bengalaru and Michael Erman in New York; writing by Caroline Humer; Editing by Chizu Nomiyama, Aurora Ellis and Kirsten Donovan)

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Rheumatoid arthritis drug cuts coronavirus deaths in clinical trial, Eli Lilly says

Eli Lilly and Company said on Thursday that there were fewer deaths among coronavirus patients who were given a combination therapy involving its rheumatoid arthritis drug and Gilead Sciences Inc’s GILD.O remdesivir drug compared to those who only received remdesivir.

The company has previously shared that the drug, baricitinib, which is marketed as Olumiant, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients. The findings come from a National Institute of Allergy and Infectious Diseases-sponsored trial dubbed the Adaptive COVID-19 Treatment Trial (ACTT-2).

The company previously shared that the drug, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients. 

The company previously shared that the drug, in combination with remdesivir, was shown to cut hospitalization time for coronavirus patients. 
(Photo courtesy of Eli Lilly)

In the data shared on Thursday, the company said that the largest benefits were observed in coronavirus patients requiring supplemental oxygen, and those who required high-flow oxygen/non-invasive ventilation.

CORONAVIRUS RECOVERY TIME REDUCED BY RHEUMATOID ARTHRITIS DRUG AND REMDESIVIR, ELI LILLY SAYS

“Using the ordinal scale that ranged from recovered to death, the odds of improvement in clinical status at Day 15 were 30% greater in patients being treated with baricitinib in combination with remdesivir compared with remdesivir,” the company said in a news release. “A numerical decrease in death (35%) through Day 29 was observed in patients treated with baricitinib plus remdesivir compared to remdesivir in the overall population.”

In coronavirus patients receiving oxygen, the difference was more pronounced. Mortality at Day 29 was 60% lower in patients requiring supplemental oxygen, and 43% lower for patients requiring high-flow oxygen/non-invasive ventilation.

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Baricitinib is not currently approved by the FDA to treat COVID-19, although the company is gearing up to seek Emergency Use Authorization (EUA), according to the news release.

“We are excited that these results add to the potential role for baricitinib to treat hospitalized COVID-19 patients,” Ilya Yuffa, Lilly senior vice president and president of Lilly Bio-Medicines, said in a statement. “Lilly is committed to identifying impactful preventions and treatments, and we are engaged in discussions with the FDA regarding the potential to make baricitinib available to hospitalized patients as quickly as possible.”

CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGE 

The company said it is working to have the full trial analysis completed and a peer-reviewed manuscript “available soon.”

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Eli Lilly Seeks FDA Approval On Coronavirus Treatment, Potentially Easing Rush For A Vaccine

KEY POINTS

  • Eli Lilly’s three trials over the summer yielded positive results in patients with mild- to moderate-cases of coronavirus
  • The company could have nearly 1 million doses ready for distribution by the end of 2020 with FDA approval
  • Temporary protections provided by the antibody treatment could potentially give pharmaceutical companies more time to develop stronger vaccines

Pharmaceutical company Eli Lilly & Co. asked the U.S. Food and Drug Administration Wednesday to authorize the use of a potential coronavirus treatment that’s shown promising results during clinical trials.

Eli Lilly asked the FDA to authorize the drug’s emergency use after results for their first three clinical trials all came back positive in people with mild- to moderate-cases of coronavirus. If approved, Eli Lilly said it could have 100,000 doses ready to go within a month and 1 million ready by the end of 2020.

However, it would not be used on more severe cases, since it has not proven to be as effective in treating those cases.

The drug, codenamed LY-CoV555, is in an antibody drug Eli Lilly has been developing with Canadian pharmaceutical company AbCellera Biologics Inc. AbCellera started by taking blood samples from one of the first coronavirus patients in the U.S. to recover when it began working with Eli Lilly. The two then started developing an antibody drug treatment based on the antibodies found in the patient’s blood sample.

Trials began in June, when hospitalized patients being treated for coronavirus were dosed randomly with either the drug or a placebo to measure the drugs effectiveness. After results showed the drug helps treat the virus, phase 2 trials were conducted among vulnerable populations who were randomly administered a placebo or one of two potential drugs, including alternate antibody treatment LY-CoV016.

The most recent trials were conducted in nursing homes and, as before, showed the drug helped treat the symptoms of coronavirus and could temporarily protect against it. The latter half of the results would be important because it could ease the pressure on other pharmaceutical companies to develop a full vaccine.

One company which would benefit from this, in that regard, is AstraZeneca Plc. U.S. trials for AstraZeneca’s potential vaccine have been on hold since September after one patient was diagnosed with unexpected neurological symptoms after being inoculated. Trials have continued overseas.

That said, AstraZeneca may still rush to get a vaccine out as its pledge not to profit from it runs through July 2021. Under its current contractual agreement, Astrazeneca could declare the pandemic over by then and begin profiting off its distribution. The period could be extended if AstraZeneca acts “in good faith” if the pandemic is not considered over.

The company said it expects to receive an update about possibly resuming its U.S. trials in the next two weeks.

Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company's experimental Covid-19 vaccine Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company’s experimental Covid-19 vaccine Photo: AFP / ANDREW CABALLERO-REYNOLDS

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Eli Lilly Applies For Emergency Approval For Covid-19 Antibodies

The US biotech firm Eli Lilly on Wednesday announced it was seeking an emergency use authorization (EUA) for its lab-produced antibody treatments against Covid-19, after early trial results showed they reduced viral load, symptoms and hospitalization rates.

“Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments,” said Daniel Skovronsky, Lilly’s chief scientific officer.

“Lilly is diligently working with regulators around the world to make these treatments available,” he added.

The company said in a statement that its “combination therapy” of two antibodies working together was shown to be effective in a placebo-controlled study of 268 patients with mild to moderate Covid-19.

Their analysis showed the proportion of patients with high viral load at day 7 of their illness was 3.0 percent on the therapy, compared to 20.8 percent on the placebo arm.

Improvement in symptoms was seen as early as three days after dosing.

The rate of Covid-related hospitalization and emergency visits was 0.9 percent for patients treated with combination therapy versus placebo 5.8 percent on placebo, a relative risk reduction of 84.5 percent.

The company is also studying a “monotherapy” of just one of the two antibodies, and said that parallel research showed that this was similarly effective.

The trial is ongoing and Lilly wants to recruit a total of 800 people.

Aa transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient,captured and color-enhanced Aa transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient,captured and color-enhanced Photo: National Institute of Allergy and Infectious Diseases / Handout

Lilly said it expects to have 100,000 doses of the monotherapy available this month, and a million by the end of the year. It also expects to have 50,000 doses of the combination therapy by the end of 2020.

The findings have not yet been published in a peer-reviewed journal.

Both antibodies work by binding to different parts of spike proteins on the surface of the SARS-CoV-2 virus, distorting their structure so the virus can’t invade living cells.

Antibodies are infection-fighting proteins made by the immune system and can also be harvested from recovered patients, but it is not possible to make so-called “convalescent plasma” a mass treatment.

Researchers can also comb through the antibodies produced by recovered patients and select the most effective out of thousands, and then manufacture them at scale.

US President Donald Trump, who has Covid-19, received a dose of synthetic antibodies produced by the firm Regeneron last week.

Regeneron has also reported encouraging results from its early trials, but hasn’t yet applied for emergency approval and so remains an experimental treatment.

The US Food and Drug Administration has previously granted an EUA for the antiviral remdesivir, for convalescent plasma, and for hydroxychloroquine, which was subsequently revoked over safety fears.

In addition, US health authority’s guidelines recommend the use of the steroid dexamethasone to control a damaging inflammatory response seen in later stages of Covid-19.

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