US pharmaceutical giant Merck applies for emergency use authorization for first COVID-19 pill
If the US Food and Drug Administration grants Merck an EUA for the pill, it would be the first oral antiviral for Covid-19.
US pharmaceutical giant Merck & Co Inc (MRK.N) and its partner Ridgeback Biotherapeutics has sought emergency use authorization in the US for molnupiravir, the first Covid-19 pill, after the experimental drug showed “compelling results” in clinical trials.
Designed to introduce errors into the genetic code of the virus, the pill could halve the chances of dying or being hospitalized for those most at risk of contracting severe Covid-19, according to data released earlier this month that experts hailed as a potential breakthrough in how the virus is treated.
“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’s CEO Robert Davis said in a statement.
An authorization from the US Food and Drug Administration could help change clinical management of Covid-19 as the pill can be taken at home.
The interim efficacy data on the drug, developed with Ridgeback Biotherapeutics, had heavily dented the shares of Covid-19 vaccine makers and set off a scramble among nations, including Malaysia, South Korea and Singapore, to sign a supply deal with Merck, Reuters reported.
The drugmaker has a US government contract to supply 1.7 million courses at a price of $700 per course if it receives authorization from the FDA. Merck expects to produce 10 million courses of the treatment by the end of 2021.
It has also agreed to license the drug to several India-based generic drugmakers, which are expected to supply the treatment to more than 100 low- and middle-income countries.
Molnupiravir can be given to patients at home, unlike Gilead Sciences Inc.’s antiviral remdesivir and monoclonal antibody therapies that are administered via intravenous infusion usually in hospitals or clinics. Treating Covid patients at home averts the risk they’ll transmit the virus to medical staff and other patients, a Bloomberg report stated.
(With inputs from agencies)