German pharmaceutical Merck shared that its oral antiviral molnupiravir was successful in reducing the risk of COVID-19 hospitalisation or death by approximately 50 per cent in patients suffering from mild or moderate COVID-19 in an interim analysis. The company now intends to apply to the US Food and Drug Administration and other global drug regulators for emergency use authorisation (EUA).
If approved, the drug Merck claims, would be the first approved oral antiviral medicine to treat COVID-19. This finding that the drug is successful in reducing hospitalisation and death caused due to COVID-19 emerged from the interim results Phase 3 trials of the MOVe-OUT trials conducted by Merck.
The drug molnupiravir is an investigational, orally administered antiviral that inhibits the replication of SARS-CoV-2. It has also been seen to act against the variants of SARS-CoV-2 and was also clinically successful in stopping the replication of the SARS-CoV-1 and MERS viruses.
Invented by scientists at Drug Innovations at Emory, a nonprofit initiative by Emory University, Atlanta, Merck is developing the pill for covid 19 along with Ridge Biotherapeutics.
How Do The Molnupiravir Results Benefit India?
At the height of the COVID-19 second wave in April 2021 in India, Merck declared its intent to make the drug available in India. It signed a licensure agreement with five Indian pharmaceutical firms allowing them to supply the medicines to the country. Along with accelerating the availability of the drug in India, the five generic medicine manufactures were also asked to supply this oral pill against COVID-19 to 100 other low-and-middle income countries.
Cipla Limited, Dr. Reddy's Laboratories Limited, Emcure Pharmaceuticals Limited, Hetero Labs Limited and Sun Pharmaceutical Industries Limited are the five signees from India. Cipla, Dr. Reddy's and Hetero were also supplying remdesivir produced by Gilead Lifesciences.
What Are The MOVe-OUT Trials?
Conducted against 170 planned locations in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States, the trial was meant to enroll 1500 patients.
The interim results evaluated data from 775 patients. While incidents of adverse events due to consuming the drugs were comparable in those who received the drug and the placebo (35 and 40 per cent respectively), only 7.3 per cent of participants who received the drug required hospitalisation through day 29 but 14.1 per cent of the patients who received placebos were admitted to hospitals or died.
Close to 40 per cent samples were sequenced and the trials showed that molnupiravir acted against the Delta, Gamma and Mu variants of the original SARS-CoV-2 virus.
Even though the trials are still ongoing, Merck has been developing the medicine at its facilities on its own risk. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
The pharmaceutical has also entered an agreement with the US authorities that it will give close to 1.7 million doses to the country as soon as it is approved by the regulators for use. The company is also in talks with regulatory bodies across the world for distributing molnupiravir.