Anti-viral molnupiravir gets ‘conditional recommendation’ from WHO

Even as some researchers raise safety concerns over molnupiravir, the anti-viral has received a “conditional recommendation” from the World Health Organisation.

The WHO updated its living guidelines on Covid-19 therapeutics to include a conditional recommendation on molnupiravir, the UN health agency said, making it the first oral antiviral drug to be included. “As this is a new medicine, there is little safety data. WHO recommends active monitoring for drug safety, along with other strategies to mitigate potential harms,” it added.

This is the ninth update of WHO’s living or evolving guideline on therapeutics and included an update on Casirivimab-Imdevimab, a monoclonal antibody cocktail. “Based on evidence that this combination of drugs is ineffective against the Omicron variant of concern, WHO now recommends that it is only given when the infection is caused by another variant,” it said.

The injectable antibody cocktail from Regeneron was, in fact, included in the WHO’s guideline in September 2021. The product is produced and marketed globally by Swiss drugmaker Roche. In India, Roche sells the product through Cipla. And the one-dose treatment costs close to ₹60,000. The drug had made global headlines when it was given to former US President Trump when he had tested positive for Covid-19.

But in late January, the United States Food and Drug Administration, too, restricted its use against the Omicron variant of SARS-CoV-2.

Data gaps on the pill

On molnupiravir, taking note of the concerns and data gaps, WHO said it should be given “only to non-severe Covid-19 patients with the highest risk of hospitalisation. These are typically people who have not received a Covid-19 vaccination, older people, people with immunodeficiencies and people living with chronic diseases.”

Children and pregnant and breastfeeding women should not be given the drug, it added. People who take molnupiravir should have a contraceptive plan, and health systems should ensure access to pregnancy testing and contraceptives at the point of care, the WHO explained.

The drug is approved in India, but the Indian Council of Medical Research had also sounded a similar caution on the oral drug. Merck Sharpe Dohme (MSD) (or Merck in the US and Canada) has voluntary licensing agreements with multiple Indian companies on Molnupiravir, including Dr Reddy’s Laboratories, Cipla, Sun Pharma, Hetero, Emcure, Aurobind, Torrent etc.

Treatment schedule

“Under the care of a healthcare provider, molnupiravir is given as four tablets (total 800 mg) twice daily for five days; within 5 days of the onset of symptoms. Used as early as possible after infection, it can help prevent hospitalisation,” the WHO said.

The latest recommendation comes on the back of new data from six randomised controlled trials involving 4,796 patients. This is the largest dataset on this drug so far, the WHO said.

Access issues

Molnupiravir is not widely available, but steps have been taken to increase access. WHO said it has invited manufacturers to submit their products for prequalification, and a number of manufacturers of molnupiravir are going through assessment now, it added. The availability of more quality-assured manufacturers would mean that countries have a greater choice of products and more competitive prices, it pointed out.

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