EU may consider deal on Merck's COVID pill after approval procedure begins

The European Union may consider signing a supply deal with US drugmaker Merck for its experimental COVID-19 pill, but only after the company starts the process of seeking approval for the drug in the bloc, a senior EU official said on Tuesday.

The oral antiviral treatment molnupiravir has been developed with Ridgeback Biotherapeutics. If approved by regulators, it would be the first COVID-19 drug administered orally and also the first treatment for mildly ailing patients, whereas existing drugs are mostly used to treat the critically ill.

The EU would consider a joint procurement of molnupiravir, "if Merck engages with EMA", the EU official told Reuters, referring to the European Medicines Agency.

On Monday Merck applied for emergency use authorisation in the United States, which has already secured 1.7 million courses of molnupiravir at a price of $700 per course. Washington has invested in the development of the drug.

Merck seeks first US FDA authorization for COVID-19 tablet

Throughout the pandemic, the EU has signed advance purchase deals for experimental vaccines and drugs against the coronavirus before companies applied to EMA. But the EU official said that approach had now changed because the 27-nation bloc has entered a new phase in the health crisis.

Rolling Review

With about 75% of its adult population vaccinated, the EU is now signing advance deals only when drugs have at least begun a so-called rolling review with EMA, the official said.

Under this procedure, the EU regulator assesses data as soon as they become available, instead of waiting for a formal application when all required information has been gathered.

A spokesman for the EU Commission did not comment on whether the start of a rolling review was a precondition to have an advance deal with a drugmaker. He repeated that, in theory, to launch a joint procurement, at least four EU governments and the European Commission would need to support it.

Last week, EMA said it would consider in the coming days whether to start a rolling review for molnupiravir. On Tuesday it told Reuters the rolling review had not yet begun.

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A second EU official familiar with the process said the agency was expecting data from Merck soon, and only at that point it could begin the review.

Merck did not respond immediately to a request for comment on the matter.

The first EU official said talks with Merck had not yet started, and that the number of treatments the EU could secure would depend on several conditions, including pricing.

Under its advance purchase deals, the EU reserves a number of doses of a treatment or vaccine. EU states that decide to be part of the contract can buy their share of the reserved doses once the medicine has been authorised by the EMA or by a national regulator.