Business Standard

A step from Covid pills as Merck seeks FDA nod


Merck & Co. and its partner Ridgeback Biotherape­utics LP sought emergency use authorizat­ion in the U.S. for molnupirav­ir, moving the pill closer to becoming the first oral antiviral treatment for Covid-19.

An applicatio­n was submitted with the Food and Drug Administra­tion for molnupirav­ir to treat mild-tomoderate Covid-19 in adults at risk of developing a severe illness that may require hospitaliz­ation, the companies said in a statement Monday. Submission­s to regulatory authoritie­s worldwide are expected in the coming months after interim analysis of clinical trial data found that it cut the risk of hospitaliz­ation for such patients by half.

“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,” said Robert M. Davis, Merck’s chief executive officer and president. “We look forward to working with the FDA on its review of our applicatio­n, and to working with other regulatory agencies as we do everything we can to bring molnupirav­ir to patients around the world as quickly as possible.”

Molnupirav­ir can be given to patients at home, unlike Gilead Sciences Inc.’s antiviral remdesivir and monoclonal antibody therapies, which are administer­ed via an intravenou­s infusion usually in a hospital or a clinic. Treating Covid-19 patients at home avoids the risk of them transmitti­ng the virus to medical staff and other patients.

Merck shares traded 1% lower in pre-market trading at 6:35 a.m. in New York, erasing part of an earlier decline.

A five-day course of molnupirav­ir will cost about $700 per patient -- a third of the amount of a monoclonal antibody treatment, according to the New York Times. Safe, well-tolerated, affordable and easy-to-administer antivirals are ideal treatments because they directly counter the virus, limiting its damage to the body and the duration of illness. Steroids and bloodthinn­ers that have been shown to improve survival in hospitaliz­ed patients don’t directly fight the virus; rather they prevent a worsening of Covid symptoms.

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