EU regulator set to rule on Pfizer COVID pill by end of January, ahead of Merck – source

A Pfizer employee checks boxes containing Paxlovid, COVID-19 treatment pills, at a distribution center in Memphis, Tennessee, USA, in this undated photo. Pfizer/Handout via REUTERS

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Jan 24 (Reuters) – The European Union’s medicines regulator is expected to decide whether to approve Pfizer’s COVID-19 pill at the end of this month, ahead of a final review of Merck’s similar but less effective drug in February , a source with knowledge of the matter said.

Late last year, the European Medicines Agency (EMA) gave advice to member states on how to use the two antiviral pills as emergency treatments, while carrying out ongoing reviews to help Member States to decide on rapid adoption before any formal EU-wide approval. Read more

Italy, Germany and Belgium are among a handful of EU countries that have purchased the drugs. Read more

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The EMA’s review of Merck’s (MRK.N) pill, developed with Ridgeback Biotherapeutics, is taking longer than Pfizer’s (PFE.N) because Merck released trial data in November showing that his medication was significantly less effective than previously thought.

“Merck applied earlier than Pfizer, but they sent the final efficacy data later, so it took European regulators longer to review this latest data,” the source said.

The source declined to be identified because EMA opinions are confidential.

EMA executive director Emer Cooke told Irish broadcaster RTE the regulator may be able to conclude its review of one of the antivirals this week and “is considering some more review of the second oral antiviral.” , which could push him into next month’s discussion.”

She did not identify which drug might be approved first.

As vaccines are central to the fight against the pandemic, regulators are eyeing antivirals, which can be taken at home, as a new weapon against the fast-spreading Omicron variant.

US and UK regulators have given the two drugs the green light to treat some high-risk adult patients. Read more

The EMA said Jan. 10 that it could make a decision “within weeks” on whether to approve the use of Pfizer’s Paxlovid two-drug regimen. Read more

In a clinical trial, it was nearly 90% effective in preventing hospitalizations and deaths when given at an early stage to patients at high risk of severe disease. Read more

The source also said that the EMA expects to issue its decision on Valneva’s VLA2001 COVID-19 vaccine candidate (VLS.PA) in March, in line with the timeline given by the French company on January 6.

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Reporting by Reuters journalists Editing by Josephine Mason and Mark Potter

Our standards: The Thomson Reuters Trust Principles.

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