New Delhi: MSD Pharmaceuticals, a wholly-owned subsidiary of Merck Sharp & Dohme and known as Merck & Co Inc, on Friday said it is confident in the clinical profile of molnupiravir, which demonstrated a significant reduction in the risk of hospitalisation or death in case of COVID-19 patients in the Phase-III clinical trials.
Molnupiravir is being developed by MSD and Ridgeback Biotherapeutics for the treatment of mild to moderate COVID-19.
“We provided relevant information as requested to help the DCGI determine the most appropriate use of molnupiravir in India.
“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,” MSD India said in a statement.
The company’s statement comes after ICMR Director-General Balram Bhargava said molnupiravir has major safety concerns and has not been included in the national protocol for the treatment of coronavirus.
During a press briefing earlier this week, he said the World Health Organization and the UK have not included it for treatment.
Bhargava said the US has approved it based on only 1,433 patients in which three per cent reduction was observed in symptoms in patients with mild to moderate disease.
India’s drug regulator Central Drugs Standard Control Organisation on December 28 had approved Molnupiravir for the restricted use in emergency situations in patients with COVID-19.
“Based on this emergency use, molnupiravir will be available to appropriate patients with a doctor’s prescription,” MSD India stated.
The restrictive emergency use has been granted to the eight generic manufacturers in India who have entered into voluntary licensing agreements with MSD (known as Merck in the USA & Canada), it added.
“We provided relevant information as requested to help the DCGI determine the most appropriate use of molnupiravir in India,” the company noted.
It added that molnupiravir is 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.
Based on the strong science behind the medicine and with preliminary preclinical data showing antiviral activity against Omicron, molnupiravir has the potential to become an important tool for healthcare professionals and appropriate patients, MSI India stated.
Molnupiravir is yet to be evaluated against Omicron in clinical studies, it noted.
“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,” the company stated.
Last year, MSD Pharmaceuticals had entered into non-exclusive voluntary licensing agreements with leading Indian generic manufacturers for the supply of molnupiravir.
The CDSCO had received 22 applications for manufacture and market of the drug Molnupiravir in the country.
Molnupiravir is an antiviral that inhibits SARS-CoV-2 replication by viral mutagenesis.
The UK MHRA on December 4, 2021, had granted approval for molnupiravir under special condition for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness.
The US FDA on December 23 had granted emergency use authorisation (EUA) for molnupiravir for the treatment of mild-to-moderate COVID-19.
PTI