The FDA on Thursday cleared another new pill to treat the Omicron variant, this time from Merck.
While Pfizer’s antiviral may prove to be more effective and the Merck pill has left some scientists wondering about the dangers of its mechanism of action, molnupiravir will be another weapon in the Covid-treatment arsenal. 19 for US when needed, as two Regeneron and Eli Lilly mAb treatments no longer effective against Omicron, and as supplies of a third Vir / GlaxoSmithKline mAb are very limited.
The supply of the Merck pill will not be as limited, as the United States may have around 400,000 Merck pill courses available in the next few days, and by the end of January, the United States government expects to have approximately 3 million cures of the Merck pill, which is the entire order the United States has placed.
The problem with the Merck pill is that it works by inhibiting the replication of SARS-CoV-2 through viral mutagenesis, and some scientists have expressed serious reservations about this MOA.
@FDACDERDirector @DrWoodcockFDA Before the FDA approves molnupiravir, please consider the concerns below about how its low efficacy indicates that viral replication is not being suppressed efficiently, suggesting that viable mutant viruses may be transmissible through them. patients. Thank you. https://t.co/0ZFwtlHKVj
– Michael Lin, PhD-MD 🧬 (@michaelzlin) 23 December 2021
The FDA’s Antimicrobial Drug Advisory Committee voted 13-10 last month in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing symptoms of Covid.
“Committee members who voted ‘No’ cited the following reasons for concluding that the overall benefit-risk ratio was unfavorable: 1) a high number of subjects to be treated compared to placebo, 2) unclear efficacy against Delta variant, 3) potential to induce viral mutations, and 4) risks of mutagenicity, ”according to a meeting summary.
Merck is to provide the FDA with monthly reports summarizing all findings resulting from its activities of monitoring genomic databases for the emergence of global viral variants.
As part of Thursday’s clearance, the FDA made it clear that it should be provided to those “for whom the FDA-approved alternative COVID-19 treatment options are not accessible or clinically appropriate,” which means that if the Pfizer pill is available, it might be a better option.
“I don’t think you would find anyone who would prefer the Merck pill over the Pfizer pill, given the evidence so far,” said Walid Gellad, professor of medicine at the University of Pittsburgh. Terminal news previously.
As part of the EUA, the FDA said Merck must “conduct a full investigation of the differences in efficacy seen in the first and second half” of its pivotal trial. The adcomm panelists last month focused their questioning on the cause of this drop in the prevention of hospitalizations and deaths, from 50% to 30% between the intermediate and final results. Merck and the FDA provided few details at the meeting as to why the efficacy has declined.
Unlike the Pfizer pill, the FDA also warned on Thursday that molnupiravir is not recommended for use during pregnancy because based on the results of animal reproduction studies, molnupiravir may harm the fetus.
Merck should maintain a pregnancy monitoring program to collect information from those exposed to molnupiravir during pregnancy. The FDA has also said that sexually active people with partners of childbearing potential are advised to use contraception during treatment with molnupiravir and for at least three months after the last dose.
Molnupiravir is also not authorized for use in patients under the age of 18, or for use for more than 5 consecutive days. One course of treatment is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules.