Molnupiravir has no observed safety concerns: MSD India
Hyderabad: Amid safety concerns around antiviral drug molnupiravir, the US-based pharma company MSD (Merck is known as MSD outside the US and Canada) came out in defence of its drug developed in collaboration with Ridgeback Biotherapeutics. The company in its statement on Friday, said, “We are confident in the clinical profile of molnupiravir, which demonstrated […]
Hyderabad: Amid safety concerns around antiviral drug molnupiravir, the US-based pharma company MSD (Merck is known as MSD outside the US and Canada) came out in defence of its drug developed in collaboration with Ridgeback Biotherapeutics.
The company in its statement on Friday, 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.”
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 company stated.
Molnupiravir is yet to be evaluated against Omicron in clinical studies. With the continued spread of the virus and the emergence of variants, additional treatments for Covid-19 are urgently needed.
The company further stated, the Drug Controller General of India granted restrictive emergency use for molnupiravir, for the treatment of non-hospitalised patients with confirmed Covid-19.
Based on this emergency use, molnupiravir will be available to appropriate patients with a doctor’s prescription. The restrictive emergency use was granted to the eight generic manufacturers in India who have entered into voluntary licensing agreements with MSD (known as Merck in the USA & Canada). The company said it provided relevant information as requested to help the DCGI determine the most appropriate use of molnupiravir in India.
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