Two new oral drugs approved for the Covid treatment; details here

The UK drug regulator has announced that it has given a heads up to first oral antiviral for covid-19 treatment on Thursday. The drug named ‘molnupiravir’ developed by Merck and Ridgeback has been authorised for those who have mild to moderate covid-19 symptoms or at least one risk that could lead to severe illness, the UK’s Regulatory Agency said.

On the very same day, Pfizer also announced the trial results for its COVID-19 oral antiviral drug ‘Paxlovid’ claiming that the drug has significantly helped in reducing hospitalisation and deaths with covid-19.

Currently, Molnupiravir is undergoing trials in India while in the US, it is also being evaluated by the FDA (Food and Drug Administration).

No oral antiviral drug except for Molnupiravir

There have been several drugs seen by the world throughout the pandemic but so far there have been no orally recommended drugs that got regulatory clearance in any of the country from food regulators besides molnupiravir. The other treatments as well had not given the results as expected from them.

Remdesivir, hydroxychloroquine, ritonavir and lopinavir, and interferon beta 1a were some of the covid drugs that were in trials. The WHO eventually concluded that these four drugs have little or no effect on hospitalised Covid-19 patients.

What about Molnupiravir and Paxlovid

The UK clearance to molnupiravir, and the results shown by Pfizer’s drug, has given hope that it would pave the way for more effective management of Covid-19 in all the countries. The UK regulator has in fact said molnupiravir is “safe and effective” for use. On October 27, the WHO notified that molnupiravir is being evaluated for inclusion in the WHO guidelines on Covid-19 therapeutics and is waiting for the authorisation from its regulators.
As for Paxlovid, Pzifer is planning on submitting its intermic clinical trial data to the US food regulation FDA for emergency use authorisation as soon as possible.

What about India?

Merck is currently in talks with many Indian drug manufacturers for licensing for molnupiravire. Indian drugs manufacturer Cipla on June 29 announced that Dr Reddy’s Laboratories Ltd (DRL), Emcure Pharmaceuticals Ltd, Sun Pharmaceutical Industries Ltd, and Torrent Pharmaceuticals Ltd will be collaborating for a trial of molnupiravir drug for the treatment of mild Covid patients.

A DRL spokesperson earlier stated that the trial is in progress with interim data being shared with the DCGI (Drugs Controller General of India). He also stated that the developments regarding approval in other countries are also being tracked/followed.

Hetero Labs Ltd had also submitted interim clinical data in moderate covid patients, said Central Drugs Standard Control Organisation.