In less than a fortnight after announcing promising findings on anti-viral drug molnupiravir, Merck and Ridgeback Biotherapeutics have approached the US regulatory authority, seeking emergency approvals for its use in treating Covid.
The two companies said on Monday that they have submitted an Emergency Use Authorisation (EUA) application to the US Food and Drug Administration (US FDA) on the investigational oral antiviral medicine for the treatment of mild-to-moderate Covid in adults at risk of progressing to severe Covid and/or hospitalisation.
The submission was based on positive interim findings from their Phase III trial that evaluated molnupiravir in non-hospitalised adult patients with the stated risk. “At the interim analysis, molnupiravir reduced the risk of hospitalisation or death by approximately 50 per cent...” said Merck.
Close to a dozen companies are in a race to make this drug in India, and are undertaking clinical trials on it. Merck had issued non-exclusive voluntary licences to eight companies (see info box) to make the drug for low- and middle-income countries. And five companies are, in fact, undertaking a joint clinical trial on the drug.
Two firms call off trial
Adding an element of intrigue into the positive buzz on the drug, two Indian companies undertaking trials on molnupiravir – Aurobindo Pharma and MSN Laboratories – approached the Indian regulator to discontinue trials in moderate patients. Aurobindo is one of Merck’s licencees on the drug, but is not a participant on the joint trial.
Reports suggest the decision to discontinue was because they did not find the drug significantly effective in moderate patients. The report also indicated the companies could be differing in their definition of “moderate”.
The two companies, though, are expected to continue with examining molnupiravir’s use in patients with mild illness. Merck, known as MSD outside the US and Canada, did not comment on the development.
Several voices in the international medical community are upbeat on the possibility of having a pill to treat Covid. Most of the presently available therapies are injectables. However, multiple doctors in India told BusinessLine they would wait for published details from Merck before commenting on its possible benefits.
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