USA – US regulators set to approve oral antiviral against COVID-19

Oral antiviral treatments that combat the worst effects of COVID-19 are under the regulatory microscope in the US this month.

The group that advises the Food and Drug Administration (FDA) voted to recommend Merck/MSD’s antiviral molnupiravir, which means the treatment could be authorised and made available to patients within weeks.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) became the first regulatory agencies to approve the drug in early November 2020. Merck developed molnupiravir with Ridgeback Biotherapeutics.

“With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are urgently needed,” said Dr Dean Y Li, president of Merck Research Laboratories. “That is why we are moving with speed and rigor to pursue authorisations and to accelerate broad global access to this investigational medicine.”…