MHRA is recommending the oral Covid therapeutic that market hype is calling a “game changer” for treatment of patients with mild to moderate forms of the disease caused by the coronavirus. Recipients must have at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease. The government has secured around 500,000 doses.

Britain’s green light is the first-ever regulatory approval for an antiviral to treat Covid and will be the first Covid therapeutic to be administered widely in the community. The pill, which can be taken at home, should be administered as soon as possible following a positive Covid test and within five days of the onset of symptoms, the health agency said, citing clinical data submitted by Merck.

Branded as Lagevrio in the UK, Molnupiravir is designed to introduce errors into the genetic code of the virus. It should be taken twice a day for five days. Stephen Powis, national medical director for NHS in England, told news agencies the drug would be administered to patients at higher risk of complications as Britain heads into one of the most challenging winters ever.

UK vaccines minister Maggie Throup told Parliament that the government and the National Health Service (NHS) are “working urgently get this treatment to patients initially through a national study so we can collect more data on how antivirals work in a mostly vaccinated population.” A wider rollout would follow if it is shown to be clinically sound and cost effective in reducing hospitalizations.

FDA panel to deliberate on approval this month

In mid-October, the US drugmaker applied to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir. The FDA’s advisory panel is due to meet later this month to vote on whether to recommend that the drugs regulator approve it. Data submitted to the FDA last month showed it could halve the chances of dying or being hospitalized for those most at risk of developing severe Covid-19 if given early in the illness.

Merck has estimated that the drug could generate $5 billion-$7 billion in sales through the end of 2022 if the FDA gives the green light by December.

Author: Dede Williams, Freelance Journalist