Covid-19 roundup: Ahead of FDA, EU signs off on Merck's antiviral; Distribution of mAbs in US see first uptick in 7 weeks
The European Medicines Agency on Friday said that Merck’s antiviral molnupiravir can now be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe disease.
The pill, known commercially in Europe as Lagevrio, has not yet been authorized in the US and has to be taken twice a day for 5 days. The EMA said it should be administered as soon as possible after diagnosis of Covid, and within 5 days of the start of symptoms. The quick authorization is based on data showing the drug reduced the chance that a newly diagnosed Covid-19 patient would be hospitalized or die by 50%, according to data presented by the company in October.
There are some safety concerns too, as the EMA notes:
Lagevrio is not recommended during pregnancy and in women who can become pregnant and are not using effective contraception. Women who can become pregnant must use effective contraception during treatment and for 4 days after the last dose of Lagevrio. Breastfeeding should be interrupted during treatment and for 4 days after treatment. These recommendations are given as laboratory studies in animals have shown that high doses of Lagevrio can impact the growth and development of the foetus.
Meanwhile, the EMA is also reviewing Pfizer’s oral antiviral too, which showed an 89% reduction in risk of Covid-related hospitalization or death from any cause compared to placebo. The FDA is currently reviewing EUA applications for both drugs.
Distribution of mAb treatments for Covid-19 in US see first uptick in 7 weeks
As the Delta variant surged in certain areas of the US with low vaccination rates, the Assistant Secretary for Preparedness and Response said it saw a 20-fold increase in orders for monoclonal antibody therapeutics (mAbs) to treat Covid-19.
In response to this increase in demand, ASPR transitioned to a mAb distribution system that’s coordinated by states and territories in September. While some states like Michigan and Pennsylvania have seen increases in mAb supplies from GSK/Vir, Regeneron and Eli Lilly’s products, overall as a country, the number of mAbs distributed steadily declined from almost 200,000 doses distributed in the week of Sept. 21, to only about 100,000 doses distributed nationwide for the week of Nov. 8.
Now, perhaps in preparation for rising numbers of infections as the winter months take hold, that number of mAb doses distributed has skyrocketed back up to about 175,000 doses distributed nationwide. Whether that’s just another fluctuation in the week-to-week distro system remains to be seen.
Overall, the number of doses distributed by Regeneron continues to outpace those shipped from GSK and Lilly, and another competitor may hit the market next year.