Last Updated on December 27, 2021 by The Health Master
The Subject Expert Committee (SEC) under the drug regulator of India has asked manufacturers in India to specify the category of Covid patients that are likely to receive the greatest benefit of the treatment indicated.
The committee in its last meeting earlier this month noted safety issues including embryo-foetal toxicities, bone marrow toxicity, mutagenicity, etc were reported either in-vitro or in some species of animals.
It also observed that there was a reduction in efficacy when compared with Merck’s data of the earlier interim analysis with that of the full population.
In the light of this, the SEC asked the companies about “details of risk mitigation plan and specific category of covid patients that are likely to receive the benefit of the treatment, for which the drug may be indicated,” said the minutes of the meeting.
The USFDA issued an EUA for the treatment of mild-to-moderate coronavirus disease in adults who are at high risk for progression to severe COVID-19, including hospitalisation or death.
The USFDA also said the drug should be given to patients for whom alternative COVID-19 treatment options authorised by the USFDA are not accessible or clinically appropriate.
The drug is not authorised for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth
Molnupiravir developed by MSD and Ridgeback Biotherapeutics works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. Molnupiravir is not authorised for use for longer than five consecutive days.
The SEC is reviewing the applications of Indian drugmakers such as Dr. Reddy’s, Hetero Labs, Natco Pharma, Aurobindo Pharma, Optimus Pharma, Strides Pharma, MSN Pharma, and BDR Pharmaceuticals.
It earlier reported that the panel sought more data from the companies. “The companies have submitted the data, and the SEC is expected to meet soon to review it, the person added.
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