Anti-viral drug Molnupiravir has no observed safety concerns: MSD India

US drug firm defends its drug amid concerns over safety

Amid safety concerns around Merck’s anti-viral drug Molnupiravir, the American pharma giant came out in defense of its drug developed in collaboration with Ridgeback Biotherapeutics.

In a statement, MSD (Merck is known as MSD outside the US and Canada) said, “We are confident in the clinical profile of Molnupiravir, which demonstrated a significant reduction in the risk of hospitalisation or death in our phase-3 clinical trial with no observed safety concerns when compared to the placebo group.”

The company claimed that the drug interrupts replication of the Sars-CoV-2 virus for variants like Delta, Gamma, and Mu.

The statement further said, “Based on the strong science behind molnupiravir – a single oral medicine that interrupts replication of the SARS-CoV-2 virus, with clinical data showing generally consistent efficacy across patients infected with variants of concern, Delta, Gamma, and Mu, and with preliminary preclinical data showing anti-viral activity against Omicron – molnupiravir has the potential to become an important tool for healthcare professionals and appropriate patients.”

The drug is yet to be evaluated against Omicron in clinical studies, it added.

“With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are urgently needed. Appropriate Covid-19 treatment options for individual patients should be determined only by a registered medical practitioner,” MSD India said in a statement.

After the antiviral oral drug got the nod from the Drugs Controller General of India (DCGI), Balram Bhargava, director general of the Indian Council of Medical Research (ICMR) had said that the medicine is not included in national clinical protocol as there were serious safety concerns. Bhargava had raised serious safety concerns regarding Molnupiravir saying it can cause teratogenicity (the ability to cause defects in a developing foetus), mutagenicity, and cartilage and muscle damage. Mutagenicity refers to permanent transmissible changes in the structure of genetic material of cells.

The drug cannot be given to patients of reproductive age without putting them on contraception for three months at least, as there are chances that the foetus could have abnormalities as a result.

Clinicians like Satyanarayana Mysore, HOD & consultant - Pulmonology, Lung Transplant Physician and Karnataka Covid-19 task force member have said that the government needs to clarify its stand on the drug.

MSD said, “The Drug Controller General of India (DCGI) granted restrictive emergency use for Molnupiravir, an investigational oral antiviral medicine, for the treatment of non-hospitalized patients with confirmed COVID-19. Based on this emergency use, Molnupiravir will be available to appropriate patients with a doctor’s prescription.”

The company added that the restrictive emergency use was granted to 8 generic manufacturers in India who have entered into voluntary licensing agreements with MSD. In all, 13 companies have got the DCGI nod to manufacture and market the drug.

“We provided relevant information as requested to help the DCGI determine the most appropriate use of Molnupiravir in India,” MSD India said.

Drug firms have already begun launching the drug in the country. A senior pharma executive told Business Standard on grounds of anonymity that the recent controversy around safety may deter several clinicians from prescribing the drug to Covid-19 patients.