EU REGULATOR STARTS REAL-TIME REVIEW OF MERCK’S COVID-19 PILL

Mon 25 October 2021:

The European Union’s medicines authority has started a real-time review of Merck & Co Inc’s experimental COVID-19 antiviral drug for adults, the US firm said on Monday.

The European Medicines Agency (EMA) would analyze data as soon as it became available, rather than waiting for a formal application when all essential information had been acquired, under the procedure, known as a “rolling review.”

While vaccines are the primary defense against COVID-19, Merck’s experimental drug molnupiravir, which has been shown in tests to reduce the risk of death or hospitalization in individuals most at risk of severe disease, could be a game-changer.

Merck, which is developing molnupiravir with partner Ridgeback Biotherapeutics, filed for US emergency use authorization for the drug on Oct. 11. A panel of outside advisers to the US health regulator are now slated to meet late in November to discuss whether to authorize the experimental antiviral pill.

If approved by regulators, molnupiravir would be the first COVID-19 medicine to be taken orally, as well as the first treatment for individuals who are just mildly ill, whereas current drugs are primarily used to treat the seriously ill.

The company has a $700-per-course contract with the US government to supply 1.7 million courses of the medicine. It has also recently signed supply agreements with the United Kingdom, Malaysia, and Singapore.

(with agnency)

_____________________________________________________________________________

FOLLOW INDEPENDENT PRESS:

TWITTER (CLICK HERE)
https://twitter.com/IpIndependent