- Daily Zen
FDA gives first emergency authorization to Eli Lilly for antibody treatment.
The U.S. Food and Drug Administration has given Eli Lilly & Co. the first emergency use authorization for its COVID-19 antibody treatment, which the pharmaceutical leader hopes will help infected people avoid hospitalization.
Eli Lilly’s bamlanivimab therapy will help people 12 and older with mild or moderate coronavirus get a one-time treatment through an IV. The experimental therapy is similar to the treatment President Donald Trump received after contracting the virus last month.
The latest development in COVID vaccine raised Eli Lilly stock by as much as 5.2 percent in late trading on Monday. The Indianapolis-based drugmaker’s stock had gained 8.3 percent this year.
David Ricks, Eli Lilly’s CEO, believes the bamlanivimab therapy is a “valuable tool for doctors fighting the now-increasing burden of this global pandemic.”
Anthony Fauci, the nation’s leading infectious-disease expert, has referred to antibody treatments as a “bridge to a vaccine.” Antibody treatment came under the spotlight when Trump received Regeneron Pharmaceutical’s REGN-COV2 cocktail to boost his immune response to the SARS-CoV-2 virus.
The FDA emergency clearance gives doctors an alternative for curing high-risk patients before their health deteriorates and requires immediate hospitalization. It came on the same day as a big breakthrough in the pandemic battle. Pfizer Inc. and BioNTech SE announced their COVID vaccine was found to be 90 percent more effective at an interim analysis of its Phase 3 data. The Pfizer vaccine might also receive emergency authorization sometime this year. Although, it would not be available to most U.S. citizens until 2021.
The U.S. government will pay Eli Lilly $375 million for 300,000 vials of the antibody treatment. It may also purchase an additional 650,000 treatment vials through next June for $812.5 million.
Will the drugmaker’s supply keep up with the surge in COVID cases?
Ricks is confident that the Eli Lilly will be able to “squeeze out as much supply” as it can. So far, the drugmaker has made 88,000 vials that will be shipping out to centers across the country this week.
Eli Lilly’s competitor Regeneron Pharmaceuticals has also filed for an emergency use authorization for its antibody treatment, which Trump took and hailed as a cure for COVID. The drugmaker suspended trials of its antibody cocktail ‘REGN-COV-2’ following advice from an Independent Data Monitoring Committee (IDMC) that there could be a “potential safety signal” and “an unfavorable risk-benefit profile,” with risks outweighing the benefits of the COVID cure.
The emergency authorization will serve like a temporary approval for the duration of the pandemic. In order to gain complete approval, Eli Lilly will have to submit additional research to fully define the so-called COVID cure’s safety and benefit for patients.
So far, Gilead Sciences’ antiviral drug remdesivir is the only COVID-19 treatment to receive full FDA approval. U.S. treatment guidelines also back usage of dexamethasone and other steroids for severely ill patients.
Another COVID-19 treatment to reach this status is ‘convalescent plasma,’ donated by coronavirus survivors. Studies find no COVID-19 benefit for this form of treatment.