Merck asks FDA for emergency approval of its COVID-19 antiviral pill

Pharmaceutical giant Merck and its partner Ridgeback Biotherapeutics announced Monday that it has asked the Food and Drug Administration for emergency approval of its COVID-19 pill after the investigational drug showed “convincing results” in clinical trials.

The pill, called molnupiravir, reduced the risk of hospitalization or death in patients with mild to moderate COVID-19 by about 50% in an advanced trial, according to data from a phase three clinical trial shared earlier this month.

“The extraordinary impact of this pandemic demands that we act with unprecedented urgency, and that is what our teams have done by submitting this molnupiravir request to the FDA within 10 days of receiving the data,” said Merck CEO Robert Davis in a statement.

After seeing early success with the pill in clinical trials, the company – in consultation with an independent data committee and FDA staff – decided to end the trial earlier and seek clearance of emergency use.

If the FDA grants Merck an EUA for the pill, it would be the first oral antiviral for COVID-19.

Submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral drug that can be taken at home soon after being diagnosed with COVID-19, ”said Wendy Holman, CEO of Ridgeback Biotherapeutics.

The company said it has already agreed to supply the United States with around 1.7 million treatments if it receives FDA clearance.

A five-day course of the pill would cost the federal government about $ 700 per patient, cheaper than other treatments that have been rolled out specifically for COVID-19 patients.

That hasn’t stopped fair price advocates from noting, however, that the price is around 40 times the cost of producing the pill and could mean it won’t be accessible to all patients who need it.