An expert panel advising the United States Food and Drug Administration (USFDA) has recommended an emergency-use authorisation on the antiviral pill Molnupiravir from Merck and Ridgeback Biotherapeutics used to treat Covid.
Though the advisory panel recommendation came with a slim margin in a 13:10 vote, the oral anti-viral drug inches closer to a final regulatory decision with this development.
The FDA, however, need not concur with the panel recommendation. Recently, Merck had revised its earlier statement and said that the pill was 30 per cent effective in preventing hospitalisation and death, down from the earlier mentioned 50 per cent.
Deal with Indian firms
Nevertheless, a clutch of Indian generic drugmakers, who have a voluntary licensing pact on Molnupiravir, will be watching the US developments very closely. Merck (known as MSD or Merck, Sharp and Dohme outside the US and Canada) has agreements with companies, including Dr Reddy’s Laboratories, Sun Pharma, Cipla, Aurobindo, Emcure, Hetero and Viatrias (Mylan), to make and supply Molnupiravir to low- and middle-income countries.
Incidentally, the UK has already given its regulatory go-ahead for this drug. which is presently under review with the Indian drug regulator as well.
“With the continued spread of the virus and the emergence of variants, additional treatments for Covid are urgently needed.
“That is why we are moving with speed and rigor to pursue authorisations and to accelerate broad global access to this investigational medicine,” said Dean Y Li, Executive Vice-President and President, Merck Research Laboratories, in a statement.
Merck has been producing Molnupiravir at risk and expects to produce 10 million courses of treatment by 2021-end, with at least 20 million courses to be produced in 2022, said the company.
It has already entered into supply agreements with the US government for 3.1 million courses after receiving a US approval.
Merck also has advance purchase and supply agreements for Molnupiravir with the governments of multiple countries, including Thailand, Korea and Japan, pending regulatory authorisations, it added.
Merck and Pfizer, the other company that has an oral anti-viral pill seeking approvals, have agreements with the Medicines Patent Pool to help expand the supply of the drug to more countries.