Merck & Co’s experimental antiviral drug molnupiravir has not shown “significant efficacy” against moderate Covid-19, Reuters reported quoting a source with the Drug Controller General of India (DCGI).
Aurobindo Pharma Ltd wants to discontinue a late-stage trial of molnupiravir in moderate Covid-19 patients, the regulator’s expert committee said on Friday.
“There is no significant efficacy against moderate Covid and the effective efficacy is towards mild cases,” the source said on condition of anonymity due to the sensitive nature of the discussions.
The regulator and health ministry did not immediately respond to a request seeking comment.
In an interim analysis of a late-stage clinical trial, molnupiravir is said to have reduced the risk of hospitalisation or death by 50%, Merck and partner Ridgeback Biotherapeutics LP announced earlier.
Merck earlier this year announced that it had signed non-exclusive voluntary licensing agreements for the drug with five generic manufacturers in India in a bid to accelerate availability in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.
The American pharma firm has said it will seek an emergency-use authorisation from the FDA of the drug molnupiravir.
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