US FDA advisers to review Merck’s Molnupiravir soon

The US FDA's panel will meet on 30th November, 2021 to discuss the safety and effectiveness of Molnupiravir for the treatment of mild-to-moderate COVID-19 in adults who have tested positive and are at high risk for progression to severe illness
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A panel of outside advisers to the US health regulator will meet late next month to discuss whether to authorise Merck & Co’s experimental COVID-19 anti-viral drug, the agency said yesterday.

The US Food and Drug Administration’s (FDA’s) panel will meet on 30th November, 2021 to discuss the safety and effectiveness of the drug, Molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults who have tested positive and are at high risk for progression to severe illness.

The FDA typically follows the advice of its experts but is not bound to do so.

Merck earlier this week said it filed for the US Emergency Use Authorisation (EUA) for Molnupiravir, which it is developing with partner Ridgeback Biotherapeutics. The drug would become the first oral anti-viral medication for COVID-19, if cleared by the agency.

Pfizer and Roche Holding AG are also racing to develop an easy-to-administer anti-viral pill for the disease.

Merck’s treatment cut the rate of hospitalisation and death by 50 per cent in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease, according to data released earlier.

The company has a contract with the US government to supply 1.7 million courses at a price of $700 per course. The drugmaker also recently signed deals with Malaysia and Singapore for supply of the drug.

COVID-19 drugMerckmolnupiravirRocheUS FDA
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