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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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Intensive Blood Pressure Lowering Potentially Harmful in ICH

Intensive lowering of systolic blood pressure (SBP) for patients with intracerebral hemorrhage (ICH) whose initial SBP is excessively high does not improve outcomes and is linked to safety concerns, new research shows.

Investigators found that ICH patients whose initial SBP was 220 mmHg and who underwent intensive BP lowering had twice the relative risk for neurologic deterioration at 24 hours without any reduction in hematoma expansion or 3-month risk for death and disability compared to their counterparts who underwent standard SBP lowering.

“The significantly higher rate of neurological deterioration associated with intensive treatment in patients with initial systolic blood pressure of 220 mm Hg or more warrants caution against broad recommendations for intensive systolic blood pressure reduction in patients with intracerebral hemorrhage,” the investigators, led by Iryna Lobanova, MD, Zeenat Qureshi Stroke Institute, University of Missouri, in Columbia, write.

The study was published online September 8 in JAMA Neurology.

Efficacy Unknown

American Heart Association and American Stroke Association guidelines recommend lowering SBP to 140 mmHg for ICH patients whose SBP is between 150 mmHg and 220 mmHg. However, guideline authors note that the safety and efficacy of intensive SBP lowering for patients with SBP >220 mmHg “appears to be unknown.”

To evaluate the safety and efficacy of intensive SBP reduction for ICH patients with excessively high initial SBP, the investigators analyzed data from the Antihypertensive Treatment of Acute Cerebral Hemorrhage–II (ATACH-II) trial, which compared intensive and standard SBP reduction for patients with spontaneous supratentorial ICH.

Eligible participants had SBP >180 mmHg on two measurements. The first measurement that was recorded in the emergency department was considered the initial SBP.

Consistent with practice guidelines, treatment to lower SBP before randomization was permitted. The SBP measurement recorded immediately before randomization was the prerandomization SBP.

The treatment goal was to reduce SBP to a target range of 140 mmHg to 179 mmHg in the standard reduction group and 110 mmHg to 139 mmHg in the intensive reduction group over 24 hours.

The primary outcome was the proportion of patients who died or experienced severe disability at 90 days, defined as a Modified Rankin Scale score of 4 to 6.

Secondary outcomes included neurologic deterioration, as determined by the Glasgow Coma Scale or the NIH Stroke Scale, as well as hematoma expansion and hypotension.

Neurologic Deterioration

The study included 999 participants. Of these, 228 had an initial SBP of ≥220 mmHg. The mean age was significantly less in the excessively high SBP group than in the lower SBP group, at 59.0 and 62.8 years, respectively.

The mean minimum SBP at 6 to 7 hours and at 23 to 24 hours after randomization was significantly higher among the high SBP group than the lower SBP group.

Of the 228 patients whose initial SBP was ≥220 mmHg, 110 were randomly assigned to intensive SBP reduction, and 118 were assigned to standard SBP reduction. These two treatment groups did not differ significantly with respect to age or sex distribution.

Results showed that among participants with excessively high