Doctors optimistic as Merck seeks OK for COVID drug
About 19 months into the pandemic, the pharmaceutical giant Merck has asked the Food and Drug Administration to approve an anti-viral drug the company says can help prevent serious illness from COVID for those at high risk.
The drug, known as molnupiravir, was shown to reduce the risk of hospitalization and death by 50 percent, according to Merck’s interim analysis of its Phase 3 trial.
“The benefits of this that really strike me, in contrast to what our standard of care is, is first and foremost it’s an oral drug. It’s a pill. When we think about our current COVID treatments, they require admission to a hospital or an infusion center … [this drug] has the potential for being taken at home,” said Dr. Scott Roberts, associate medical director for infection prevention at Yale New Haven Health.
The request for emergency authorization comes on the tail end of a new wave of COVID-19 infections spurred by the highly infectious delta variant.
In Connecticut, the delta variant was found to have caused nearly all cases genetically sequenced by researchers, and spurred a spike in new infections and hospitalizations in the late summer. However, cases and hospitalizations have been declining in recent weeks.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert M. Davis, chief executive officer and president of Merck, said in a statement.
Roberts said data was limited on the drug, but said he was encouraged by the information Merck has released.
“All of this makes me really optimistic, I am really excited to see the full data release from Merck,” Roberts said.
With the virus still circulating, Dr. Asha Shah, director of infectious diseases at Stamford Health, said molnupiravir could be a “game-changer.”
“It was refreshing to see this because it’s tackling the pandemic from a different angle. Vaccines are for prevention, this is for treatment — outpatient treatment,” Shah said.
Merck’s request for emergency use of its COVID-19 anti-viral drug comes amid a continued push to increase vaccination rates locally and across the nation. In Connecticut, nearly 80 percent of all eligible residents have been fully vaccinated, a number that has been increasing modestly in the fall.
Along with the effort to drive up rates, the state’s vaccine providers are in the early stages of administering booster shots to eligible individuals, including those working and living in high-risk settings, who have already finished their two-shot course of the Pfizer-BioNTech vaccine.
It was unclear when the FDA would review data for molnupiravir. The federal regulator was expected this week to consider data from Moderna and Johnson & Johnson relating to associated booster shots for the companies vaccines.
Despite no promise that it will receive federal approval, Merck said it has been manufacturing millions of doses of the drug in anticipation the company will get the necessary authorization. Merck, in announcing that it had made the request from regulators, said Monday that it has 1.7 million courses of the drug ready to give to the U.S. government.
Roberts said it appears the drug would be offered as a five-day course of two pills a day.
“I think it’s really nice to have an additional tool to help those who are diagnosed with COVID to get better outcomes,” Roberts said.