Drugmaker Merck has asked US regulators Monday to authorize its pill for treating COVID-19 in what would add an entirely new and easy-to-use weapon to the world's arsenal against the pandemic. Merck said Monday it has asked the Food and Drug Administration to authorize emergency use of its experimental antiviral pill to treat mild to moderate COVID-19 in adults. The US drugmaker's request came after phase three clinical trial data released Oct. 1 showed that the medication — known as molnupiravir — reduced the chances that patients newly diagnosed with COVID would be hospitalized by about 50%. If cleared by the FDA — a decision that could come in a matter of weeks — it would be the first pill shown to treat the illness. All other FDA-backed treatments against COVID-19 require an IV or injection. An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on US hospitals and helping to curb outbreaks in poorer countries with weak health care systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations. Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. "The value here is that it's a pill so you don't have to deal with the infusion centers and all the factors around that," said Dr. Nicholas Kartsonis, a senior vice president with Merck's infectious disease unit. "I think it's a very powerful tool to add to the toolbox." The drug works by inhibiting the replication of the virus inside the body. Unlike Gilead Sciences' intravenous drug remdesivir, Merck's molnupiravir can be taken by mouth. If approved by US regulators, it would be the first pill to treat COVID, a potentially game-changing advancement in the fight against the virus, which is killing an average of more than 1,600 Americans per day. "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," Merck CEO Robert Davis said in a press release. The pill could be available to Americans by late this year. Merck said it is actively working with regulatory agencies worldwide to submit applications for emergency use or authorization "in the coming months." The company agreed earlier this year to supply the US with around 1.7 million courses of molnupiravir if it receives emergency use authorization or full approval from the FDA. According to The New York Times, a five-day course of the medication will cost the federal government about $700 per patient, a third of the current cost of monoclonal antibodies. While vaccinations remain the best form of protection against the virus, US officials and health experts hope a pill like Merck's will keep the disease from progressing in those who do get infected and prevent trips to the hospital. Other drugmakers are also working on antiviral pills. One created by Pfizer, which developed the first authorized COVID vaccine in the US with BioNTech, could be available by the end of this year, Pfizer CEO Albert Bourla told CNBC in April. — Agencies
