Merck Covid pill gains US clearance for high-risk adults

Merck & Co.’s Covid-19 pill was cleared by U.S. regulators, giving high-risk patients another at-home treatment option at a time when the omicron variant is causing cases to surge.
 

The drug, molnupiravir, received emergency authorization on the heels of Pfizer Inc.’s competing pill that was cleared Wednesday, Paxlovid. Together, the treatments promise to provide a new way to keep a sharp rise in infections from overwhelming U.S. hospitals.

Molnupiravir, developed by Merck with partner Ridgeback Biotherapeutics LP, is intended to treat Covid in nonhospitalized people 18 and older at risk of developing severe illness. A study showed it reduced the risk of hospitalization or death among adults with mild to moderate disease by 30%. 

Molnupiravir works by introducing errors in genetic material to ultimately stop the virus’s replication, but it may affect growing human cells. The FDA said that pregnant people be advised of potential risks to the fetus before receiving the drug. 

In November, a panel of outside advisers to the FDA debated whether the drug was safe for wide use. Some expressed concern that it could lead to mutations in the virus that might make it more dangerous or transmissible, or that it could pose risks for pregnant people, and that its low efficacy in the clinical trial meant its risks outweighed its benefits. Ultimately, a divided panel voted to back the treatment by a narrow margin.

Merck has said molnupiravir doesn’t pose long-term risks.

Currently, patients who could become seriously ill with Covid are given infused drugs in hospitals or clinics, whereas a five-day course of molnupiravir can be taken at home. 

The U.S. has already reached a contract with Merck for $1.2 billion to get 1.7 million courses of treatment, meaning a five-day course will cost the government about $700 per patient. Molnupiravir will see about $2.5 billion in global revenue next year, according to an estimate from Airfinity Ltd.

Meanwhile, Pfizer is already pulling in huge profits from its Covid vaccine and expected to reap about $17 billion from sales of Paxlovid in 2022, the London-based data firm said. 

Government officials have said they expect to have 400,000 courses of Merck’s treatment available initially, and expect to get 3 million courses -- the U.S. government’s entire order -- by the end of January.