Lilly Seeks Emergency Authorization for Covid Antibody Drug
Eli Lilly & Co. asked U.S. drug regulators to authorize emergency use of its experimental Covid-19 antibody therapy.
(Bloomberg) -- Eli Lilly & Co. asked U.S. drug regulators to authorize emergency use of its experimental Covid-19 antibody therapy after data showed the treatment reduced hospitalizations.
The Indianapolis-based pharmaceutical giant has approached the U.S. Food and Drug Administration for authorization of the treatment it’s developing with Canadian biotech AbCellera Biologics Inc., according to a statement Wednesday. It would allow high-risk patients recently diagnosed with mild-to-moderate Covid-19 to receive the therapy.
Antibodies from Lilly and Regeneron Pharmaceuticals Inc. could provide a powerful addition to the handful of treatments doctors are now using to treat Covid-19, which has spread around to almost 36 million people. Antibodies are considered one of the most promising potential therapies for Covid-19, and came into the spotlight last week after President Donald Trump received Regeneron’s experimental drug.
Bridge to Vaccine
The antibodies are viewed as a bridge to a vaccine, potentially helping people with early symptoms from developing severe cases that land them in the hospital. They also are being studied as short-term treatments that could rapidly be given to people such as nursing home residents or staff who may have been exposed during a local outbreak to prevent them from getting sick.
Lilly’s shares rose as much as 3.1% in early New York trading. Regeneron’s rose as much as 1.3%.
The initial emergency authorization request is for a single antibody treatment, based on promising results announced last month. But Lilly is also studying a cocktail of two antibodies, and expects to approach regulators for authorization in November and seek full approval for the combination therapy in the second quarter of 2021. Early results from a trial showed the cocktail reduced virus levels in patients with mild to moderate Covid-19 and cut the rate of hospitalizations and emergency room visits, according to the statement.
“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,” Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in the statement. “Lilly is diligently working with regulators around the world to make these treatments available.”
Monoclonal antibodies are artificial versions of proteins the immune system naturally makes to fight off infection. They block the coronavirus spike protein, the same key target of vaccines.
Regeneron and Lilly are considered front-runners in a burgeoning race to bring the antibody treatments for Covid-19 to market. AstraZeneca Plc and GlaxoSmithKline Plc with its partner Vir Biotechnology Inc. also have antibody products in development.
The antibodies are more difficult to produce in large quantities than a vaccine, and supply is a potential issue. Lilly said it would have 100,000 doses of the single-antibody product available in October, using the lowest of three doses studied. It will have up to one million doses of the low monotherapy dose available by the end of the year it said.
Supplies of the combination therapy are much more limited, with only about 50,000 doses available this year, it said. The cocktail adds in a second antibody that Lilly licensed from Shanghai Junshi Biosciences Co.
Lilly and AbCellera’s monotherapy antibody treatment, known as LY-Cov555, reduced the rate at which symptomatic patients were hospitalized or sent to emergency rooms compared to a placebo, according to interim study results released by the company in September. At the middle of the three doses studied, it also reduced patients’ viral load.
©2020 Bloomberg L.P.