Taking a significant step towards countering COVID-19 in India, drug major Mankind Pharma has announced the launch of the oral anti- COVID pill "Molulife"(Molnupiravir 200mg). Molnupiravir (MK-4482 / EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that works by introducing RNA-like building blocks into the SARS-CoV-2 virus, the causative agent of...
Taking a significant step towards countering COVID-19 in India, drug major Mankind Pharma has announced the launch of the oral anti- COVID pill "Molulife"(Molnupiravir 200mg).
Molnupiravir (MK-4482 / EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that works by introducing RNA-like building blocks into the SARS-CoV-2 virus, the causative agent of the COVID-19 genome as it multiplies, creating numerous mutations, disrupting replication, and killing the virus.
Thus, Molnupiravir inhibits viral propagation through lethal mutagenesis by introducing error catastrophe in the viral genome. Molnupiravir targets the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) the same way other nucleoside analogs do and mediates replication and transcription of the coronavirus genome.
The safety and efficacy of the drug compared to placebo was analyzed in the MOVe-OUT trial conducted at 170 planned sites in countries across the world that evaluated Molnupiravir in non-hospitalized adult patients with mild to moderate COVID-19 with symptom onset within five days prior to randomization who were at high risk for progressing to severe COVID-19 and/or hospitalization
The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of Molnupiravir 800 mg twice daily for five days compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.
The recently reported results of all enrolled participants (n=1433) showed that Molnupiravir reduced the risk of hospitalization or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the Molnupiravir group, for an absolute risk reduction of 3.0% (95% confidence interval [CI]: 0.1, 5.9; nominal p- value=0.0218) and a relative risk reduction of 30% (relative risk 0.70; 95% CI: 0.49, 0.99). Nine deaths were reported in the placebo group, and one in the Molnupiravir group.
The drug is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of Molnupiravir in preventing the spread of COVID-19 within households.
On 23 rd December 2021, U.S. Food and Drug Administration also issued an emergency use authorization (EUA) for Merck's Molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.
Post the USFDA nod, the Indian Drug Regulator, Drugs Controller General of India (DCGI) which was analyzing the drug also gave its green signal for restricted emergency use for the treatment of adult patients.
With the nod, Mankind Pharma known for its affordable medicines in partnership with BDR Pharma plans to make Molulife (Molnupiravir 200mg) available at a mass scale in India to strengthen the COVID-19 fight in the country.
Dr. Sanjay Koul, Senior President, Mankind Pharma said, "A pill for COVID-19 is bound to go miles in strengthening defense against COVID-19 battle. Mankind with its motto 'Serving Life'- will make Molulife available in every nook and corner of the country. The company is focusing on providing a range of medicines for the management and treatment of COVID-19 in India."
Having begun its journey in 1995, Mankind Pharma operates in 34 overseas destinations leveraging 14000 happy employees and is now one of the leading Pharma Manufacturing Companies in India.
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