South Florida Sun-Sentinel (Sunday)
Lilly seeks emergency antibody drug use
A drug company says it has asked the U.S. government to allowemergency use of an experimental antibody therapy based on early results from a study that suggested the drug reduced symptoms, the amount of virus, hospitalizations and ER visits for patients with mild or moderate
COVID-19.
Eli Lilly and Company announced the partial results Wednesday inanewsrelease; they have not yet been published or reviewed by independent scientists.
Its drug is similar to one President DonaldTrumpreceived last week from Regeneron Pharmaceuticals Inc. These medicines supply concentrated versions of specific antibodies to help the immune system clear the coronavirus that causes COVID-19. They’re given as a one-time treatment through an IV.
Lilly has already started making one of the two antibodies in its drug, betting that ongoing studies would prove itworthwhile.
It’s not clear if the evidence will beviewedas strongenoughfor the Food and Drug Administration to grant emergency use authorization, as it has done for the antiviral drug remdesivir.
The results are an interim look at a mid-stage study in which 112 people received the antibodies and 156 got a placebo. The amount of virus was significantly lower 11 days later in those given the drug — the main goal of the study.
Virus also was lower at earlier time points as well. Symptom scoreswere better at three days.
About 5.8% of patients given placebo required hospitalization or an emergency roomvisit versus 0.9% of those given the antibodies. The company said there were no serious drug-related side effects.
The United States leads the world with more than 7.5 million infections and over 211,000 deaths from COVID-19, according to JohnsHopkinsUniversity.