EU regulator starts real-time review of Merck’s COVID-19 pill

Merck said today that the European Union’s (EU) drug regulator has initiated a real-time review of its experimental COVID-19 antiviral drug for adults.

Under the procedure, also known as a “rolling review,” the European Medicines Agency (EMA) would assess data as soon as it becomes available, instead of waiting for a formal application when all required information has been gathered.

While vaccines are the main weapons against COVID-19, Merck’s experimental pill Molnupiravir could be a game-changer after studies showed it could halve the chances of dying or being hospitalised for those most at risk of contracting severe illness.

Merck, which is developing Molnupiravir with partner Ridgeback Biotherapeutics, filed for the US Emergency Use Authorisation (EUA) for the drug on 11th October. A panel of outside advisers to the US health regulator are now slated to meet late in November to discuss whether to authorise the experimental antiviral pill.

Molnupiravir, if approved by regulators, would be the first COVID-19 drug administered orally and also the first treatment for mildly ailing patients, whereas the existing drugs are mostly used to treat the critically ill.

EMA’s human medicines committee (CHMP) has started a rolling review of the oral antiviral medicine Molnupiravir (also known as MK 4482 or Lagevrio), developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics for the treatment of COVID-19 in adults, EMA said in a release.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory (non-clinical data) and clinical studies. These studies suggest that the medicine may reduce the ability of SARS CoV 2 (the virus that causes COVID-19) to multiply in the body, thereby preventing hospitalisation or death in patients with COVID-19, it also added.

EMA will evaluate more data on the quality, safety and effectiveness of the medicine. The rolling review will continue until enough evidence is available for the company to submit a formal marketing authorisation application.”

The Agency will assess the compliance of Molnupiravir with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review, it further said.

EMA will communicate further when a marketing authorisation application for the medicine has been submitted.

The drugmaker has a contract with the US government to supply 1.7 million courses of the drug at a price of $700 per course. It also recently signed supply deals with countries including Britain, Malaysia and Singapore.