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EMA Begins Rolling Review of Molnupiravir

26.10.2021 - The European Medicines Agency (EMA) has begun a rolling review of US Merck & Co’s oral antiviral molnupiravir as a candidate to treat Covid-19. The EU drugs regulator said it would assess data as soon as it becomes available, before the company submits a formal application containing all the required safety and efficacy data.

On Oct. 11, the US drugmaker applied to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) of the pill it developed together with Ridgeback Biotherapeutics. Initial studies showed it could reduce the chances of dying or being hospitalized for those at highest risk of contracting severe illness.

The FDA’s advisory panel is due to meet late in November to discuss whether to recommend the candidate for authorization. If cleared, molnupiravir would be the first Covid-19 drug to be administered orally and also the first antiviral given to the patients who are not critically ill. The pill is seen as having several additional advantages over the treatments produced by Gilead, Regeneron and Eli Lilly, which require being administered at a very early stage in the infection and must be injected.

Merck & Co has a contract to supply the U.S. government with 7 million courses of the drug at a price of $700 per course. The company has said it will produce 10 million courses by the end of this year. To distribute them equitably, it has agreed to license the treatment to several India-based generics makers that in turn are expected to supply more than 100 low- and middle-income countries worldwide.

In the developed world, Merck has already signed supply deals with the UK, Malaysia and Singapore. An EU official told Reuters earlier this month that the Commission was also considering signing a supply agreement for molnupiravir, but would wait until after the company formally seeks approval.

Author: Dede Williams, Freelance Journalist

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