Merck says no safety concerns observed in molnupiravir phase-3 trial, shared relevant data with DCGI – ET HealthWorld


Merck Sharp & Dohme (MSD) on Friday said its COVID antiviral molnupiravir has cut the risk of hospitalization or death in Phase 3 clinical trial with no observed safety concerns when compared to the placebo group.

The company said it has provided relevant information as requested to help the DCGI determine the most appropriate use of molnupiravir in India.

The statement comes after ICMR didn’t add the drug as part of national protocol citing safety concerns.

“We are confident in the clinical profile of molnupiravir,” MSD India spokesperson said in a statement.

MSD also said while molnupiravir has yet to be evaluated against Omicron in clinical studies, it interrupts replication of the SARS-CoV-2 virus, with clinical data showing generally consistent efficacy across patients infected with variants of concern.

“..with preliminary preclinical data showing antiviral activity against Omicron – molnupiravir has the potential to become an important tool for healthcare professionals and appropriate patients,” MSD said.

MSD’s statement comes days after the Indian Council of Medical Research (ICMR) didn’t include the antiviral to the national COVID treatment protocol citing ‘major safety concerns.’

Balram Bhargava, the Director General of the state-run ICMR at a press briefing on Wednesday said the antiviral can cause teratogenicity (defects in developing fetus), mutagenicity (genetic mutations) and can also cause cartilage damage.

Bhargava went on to add that molnupiravir trial based on 1,433 patients saw a 3% reduction in serious-moderate COVID disease. He defended ICMR’s decision by saying that even the World Health Organisation (WHO) and the United Kingdom didn’t include the drug.

ICMR’s stand to not include the drug in the national protocol has taken wind out of pharmaceutical companies who are in a race to launch the generic brands of the drug at a time when COVID cases in India are surging. Dr Reddy’s and Mankind have announced the most affordable generic versions at Rs 1400 for full course of treatment.

The Drug Controller General of India (DCGI) granted restrictive emergency use for molnupiravir for the treatment of non-hospitalized patients with confirmed COVID-19. The government said about 13 manufacturers in India will be producing the drug.

Based on this emergency use, molnupiravir will be available to appropriate patients with a doctor’s prescription.

Molnupiravir is being developed by MSD and Ridgeback Biotherapeutics for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-CoV-2 diagnostic test and who are at high risk for progression to severe COVID-19, including hospitalization or death. The drug has been approved in the US, UK and other countries. MSD has entered into voluntary licensing agreements with eight generic manufacturers for launching the generic version in India and several other low and middle income countries.





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