Pharma biggies vouching for ‘Molnupiravir’, an anti-covid capsule, effective on omicron – Know it all

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Molnupiravir is being used to treat mild-to-moderate coronavirus disease (COVID-19) in adults that have a positive direct SARS-CoV-2 viral test and are at a high risk of developing severe COVID-19. Molnupiravir is an antiviral medicine that suppresses the replication of some RNA viruses. It is sold under the brand names Lagevrio and others. It’s used to treat COVID-19 in people who have been infected with the SARS-CoV-2 virus.

What is Molnupiravir?

Molnupiravir is a prodrug of the synthetic nucleoside derivative N4-hydroxycytidine that works against viruses by causing copying errors during viral RNA replication. Molnupiravir is available in 200 mg hard capsules for oral administration in clinical trials.

Molnupiravir 800 mg (four 200 mg capsules) taken orally every 12 hours with or without food for five days is the recommended dose regimen. The antiviral ribonucleoside analogue N-hydroxycytidine is the 5′-isobutyrate prodrug of Molnupiravir (NHC).

Background

  • Molnupiravir was developed at Emory University’s Drug Innovation Ventures at Emory (DRIVE) to treat influenza, however it was apparently cancelled due to mutagenicity concerns. 
  • Then it was purchased by Ridgeback Biotherapeutics, a Miami-based firm that eventually worked with Merck & Co. to further develop the medicine. 
  • Molnupiravir was licensed for medical use in the United Kingdom in November 2021, based on positive findings in placebo-controlled double-blind randomised clinical trials.
  • Molnupiravir was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in December 2021 for use in select populations where alternative treatments are not practicable.
  • Merck and the Medicines Patent Pool (MPP) signed a voluntary licensing agreement in September 2021, allowing MPP to sublicense Molnupiravir and supply the COVID-19 oral medicine to 105 low- and middle-income countries. The initial US government purchase cost around $712 per course of treatment although generic medication in developing nations might cost as little as $20.

Molnupiravir can be used against Omicron

According to available evidence, both Merck’s (MRK.N) and Pfizer’s (PFE.N) COVID-19 antiviral medicines are effective against the Omicron strain of the coronavirus, according to a top US FDA official.  

“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness,” said Dr. Patrizia Cavazzoni. 

Both medications interfere with how the virus multiplies, a process that isn’t altered between variations, according to the researchers.The availability of other treatments should be the first consideration for doctors wishing to prescribe Merck’s Molnupiravir, said Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

Following the Drugs Controller General of India’s emergency use authorization for the oral antiviral medication, they made their announcement (DCGI). The majority of the companies had signed a non-exclusive voluntary licensing arrangement with Merck Sharp Dohme (MSD) to produce and supply Molnupiravir in India and over 100 other low- and middle-income countries (LMICs).

Several businesses that have acquired DCGI approval and are preparing to launch the oral medicine include Torrent Pharma, Hetero, Optimus Pharma, and Natco Pharma. Cipla, Sun Pharma, and Dr. Reddy’s Laboratories were among the pharma companies that announced on Tuesday that Molnupiravir capsules will be available soon.

Here are some Pharma prominents that are all ready to launch Molnupiravir in India:

  • Natco Pharma will sell Molnupiravir as ‘Molnunat’ and It will be reasonably priced and available this week, according to the pharmaceutical company.
  • Torrent Pharma will be introducing the drug under the brand name ‘Molnutor’. The firm’s Executive Director of India region, Aman Mehta said “Molnupiravir will be an important addition to our healthcare system’s ammunition in the fight against COVID-19.”
  • Cipla has announced that it will market Molnupiravir under the brand name ‘Cipmolnu‘. Cipla’s 200mg capsules will be available in pharmacies and COVID treatment centres around the country in the near future.
  • Dr. Reddy’s said it would soon launch its Molnupiravir 200mg capsules under the brand name ‘Molflu‘ in the country. Co-Chairman and MD G.V. Prasad said, “The approval to launch Molnupiravir is an important development not only as a treatment option, but also for the collaborative manner in which Indian pharma companies came together.”

Dr. Reddy’s-led consortium of pharma companies collaborated to jointly sponsor, supervise, and monitor a Phase III clinical trial in India, and presented the findings to the Subject Expert Committee (SEC) that advises the DCGI in a first-of-its-kind collaboration in the Indian pharmaceutical industry. 

  • Sun Pharmaceutical Industries announced that the DCGI has granted an EUA to one of its wholly owned subsidiaries to manufacture and market a generic version of MSD and Ridgeback’s Molnupiravir under the brand name ‘Molxvir‘. “We will make Molxvir available to patients at an affordable price… in a week’s time,” said Kirti Ganorkar, CEO of India Business, Sun Pharma.

The drug’s suggested dosage is 800 mg twice daily for five days. Molnupiravir treatment is substantially shorter than other medications, which is a key benefit because it decreases pill burden and improves compliance, according to Sun pharma.

  • Optimus Pharma’s Chief Managing Director, D. Srinivasa Reddy stated, “We want to cover maximum demographic diversity into our trial in order to obtain data across the different geographical regions of the country and conclusive evidence that Molnupiravir is able to bring about viral load reduction over 5 days of treatment duration,”
  • Hetero, a Hyderabad-based pharmaceutical company, has acquired approval to produce and distribute molnupiravir 200 mg capsules as ‘Movfor’. The medicine will be sold in a 40-capsule box, according to the business. Movfor will be manufactured commercially at Hetero’s plants in Telangana and Himachal Pradesh, according to Group B Chairman Partha Saradhi Reddy.

Let’s see how an effective role the drug will play in fighting the upcoming and existing variants of COVID-19. Keep in loop with us to know regular updates of Molnupiravir.

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