Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data

Drugmaker Eli Lilly is hoping to score an emergency use authorization from the Food and Drug Administration on the back of data for its monoclonal antibodies against Covid-19.

The Indianapolis-based company said Wednesday that it has sent a request for an EUA from the FDA for the drug LY-CoV555 (bamlanivimab) as a monotherapy and will follow that with another EUA next month for that drug in combination with LY-CoV016 (etesevimab). An application for approval of the vaccine could come in the second quarter of next year. The two drugs target different regions of the spike protein of the SARS-CoV-2 virus.

Lilly is one of several companies developing purpose-built antiviral monoclonal antibodies for Covid-19, two other prominent players being Regeneron Pharmaceuticals and Vir Biotechnology. The one antiviral treatment with an EUA, Gilead Sciences’ Veklury (remdesivir), was originally developed for Ebola virus and later showed efficacy against coronaviruses and is a small-molecule drug.

Shares of Lilly (NYSE: LLY) were up around 2.8% on the New York Stock Exchange in midday trading Wednesday. Shares of Regeneron (Nasdaq: REGN) were up about 1.6% on the Nasdaq, while shares of Vir (Nasdaq: VIR) were mostly flat.

“We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat Covid-19 in patients with a high risk for serious outcomes,” Lilly Chief Scientific Officer Daniel Skovronsky said in a statement. “Lilly is diligently working with regulators around the world to make these treatments available.”

According to data on the combination of bamlanivimab and etesevimab from the Phase II BLAZE-1 clinical trial – in which 112 patients received each antibody at 2,800mg, and 156 got placebo – there was a statistically significant reduction in viral load among patients at day 11, thus meeting the trial’s primary endpoint. Viral levels were also reduced at day 3 and day 7. Among patients in the treatment arm, 3% had a persistent high viral load at day 7, compared with 20.8% in the placebo arm.

No emergent, putative resistant variants of the SARS-CoV-2 virus have been observed so far, the company said. The purpose of using antibody cocktails is to overcome potential resistance mechanisms.

The latest news follows the announcement in the middle of last month of interim data on bamlanivimab as a monotherapy, which likewise showed a statistically significant reduction in viral load compared with placebo.

Photo: appledesign, Getty Images

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