US pharmaceutical giant submits request for FDA approval for molnupiravir pill to treat mild-to-moderate COVID-19 cases.
US pharmaceutical company Merck has requested emergency authorisation for its experimental pill to treat mild-to-moderate cases of COVID-19, in what would add a promising, new tool to the global fight against the virus.
Merck submitted the application for molnupiravir, which it said earlier this month was shown to reduce coronavirus hospitalisations by 50 percent in early trials, to the US Food and Drug Administration (FDA) on Monday.
Merck, which is called MSD outside the United States and Canada, said it was working “with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months”.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency,” Robert Davis, the company’s chief executive officer and president said in the statement.
An antiviral pill that people could take at home to reduce their symptoms and speed up recovery could prove groundbreaking, easing the crushing caseload on US hospitals and helping to curb outbreaks in poorer countries with weaker healthcare systems.
It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
Top US health officials continue to push vaccinations as the best way to protect against COVID-19, however.
“It’s much, much better to prevent yourself from getting infected than to have to treat an infection,” Dr Anthony Fauci said while discussing Merck’s drug last week.
The FDA will scrutinise company data on the safety and effectiveness of the drug before rendering a decision.
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 hospitalisation.
The drugmaker has a US government contract to supply 1.7 million courses at a price of $700 per course. 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.
In a late-stage clinical trial, Merck and Ridgeback Biotherapeutics evaluated data from approximately 770 patients – roughly half of whom received either a five-day course of the pill, while the other received a placebo.
All the patients had lab-confirmed COVID-19 with symptoms that developed within five days of them being assigned to their respective groups.
Of the patients who received molnupiravir, 7.3 percent were hospitalised by day 29, compared with 14.1 percent of those on a placebo – a relative risk reduction of about 50 percent.
Importantly, no deaths were reported in patients who received molnupiravir, as compared with eight deaths in patients who received placebo.
The data from the trial has not yet been published or peer-reviewed.