The makers of what could be the first antiviral pill for COVID-19 said Friday that they will request emergency use authorization in the US as soon as possible. An independent board of experts monitoring the clinical trial of molnupiravir from drug-maker Merck and Ridgeback Biotherapeutics recommended it be halted early after the drug was found to reduce the risk of hospitalization and death due to COVID-19 by almost 50%, reports the Washington Post. The trial involved unvaccinated people with COVID-19 (including variants gamma, delta, and mu) who had at least one risk factor for severe disease.
Some 385 participants took molnupiravir within five days of symptoms while 377 took a placebo, per USA Today. Among the first group, 28 people (7.3%) were hospitalized within a month, compared to 53 people (14%) in the placebo group, eight of whom died. The safety board decided it would be unethical to enroll another 750 participants, half of whom would receive a placebo, as planned. One standout observation: The head of Merck Research Laboratories says the results suggest molnupiravir is more effective against SARS-CoV-2 than Tamiflu is against the flu.
If emergency use authorization is granted, molnupiravir would join remdesivir as one of two approved early treatments for COVID-19; as with approved monoclonal antibody therapies, remdesivir must be administered intravenously, reports the AP. With molnupiravir, a person who tests positive for COVID-19 could take two small capsules twice per day for five days. The pill works by messing with an enzyme the coronavirus uses to copy its genetic code and reproduce itself. As molnupiravir is designed to keep the virus from replicating, it may also prevent mutations.
The drug has been licensed to five Indian drug manufacturers to hasten availability to moderate- and low-income countries, with the Post noting it could be crucial in those places, where vaccination rates are low and it's tougher to make widespread use of drugs that have to given by IV. Merck, which plans to produce 10 million courses of treatment by the year's end, says there will be a "tiered pricing approach," with higher-income countries paying more and lower-income countries paying less. The US government has already committed to pay $1.2 billion for 1.7 million courses, or around $700 each, if approved. (Pfizer and Roche/Atea Pharmaceuticals also have antiviral drugs in clinical trials, while several other companies are working on their own.)