Amidst all the bad Covid news coming out of India there could be a glimmer of hope. As reported previously American Pharma major Merck has developed a drug called Molnupiravir – a 200 mg capsule. This oral treatment has to be taken at home for 5 days and works to completely eliminate the new Coronavirus from the body.
We have learned that one leading Indian pharma company is working closely with Merck to introduce Molnupiravir in India at the earliest.
This drug was jointly developed by Ridgeback Biotherapeutics (Rigibel) in Germany and Merck in the United States and has successfully completed the first and second phase of clinical trials in Humans and the current phase 3 clinical trial is nearing the end and the results are very promising. It could hit the market within 4 to 5 months.
What’s needed to expedite the introduction of this drug in India currently is emergency use authorisation by the Drugs Controller General of India (DCGI).
Just today the apex drug regulating body issued an emergency use approval to Zydus Cadila for the use of its antiviral drug Virafin, which has been seen to reduce the need for oxygen support and improve recovery time amongst moderate cases of Covid. Going forward, with mutations in the virus and building pressure on the healthcare system it will be important to introduce more drugs that can be administered orally at home so patients don’t reach the stage where they need to be hospitalised. Which is why emergency approval for a drug such as Molnupiravir could be a game changer say industry insiders. The drug works by reducing viral replication.
According to molecular epidemiologist Dr Jill Roberts who was quoted in wtsp.com – Tampa Bay on March 26th – during an animal study on ferrets they tried to get coronavirus to spread and it wouldn’t. So while it is a treatment designed to prevent hospitalisations and fatality, it also seems to prevent transmission. In the event of mutants that actually circumvent the vaccine, this drug will still work. At a time when the other major antiviral – Remdesivir is in acute shortage and mired in controversy, this is welcome news.
In pandemic situations, regulatory authorities of individual countries have developed procedures to issue interim approvals for drugs and vaccines if there is sufficient evidence to prove that a product is safe and effective.
Molnupiravir is in the final stages of human trials in the US and UK after it significantly decreased coronavirus levels and lung damage in Hamsters, however no country has granted it emergency approval as yet.
Industry Insiders say India could set an example for the world and be the first to issue emergency use authorisation for Molnupiravir, especially now since Merck is already working closely with an Indian pharma major and they could bring the product to the market very quickly. It is up to the governments – central and state to impress upon the regulatory authorities to examine this proposal and grant an expedited license, cut the red tape and make India a trailblazer.