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EU regulator set to rule on Pfizer COVID pill by end-Jan, ahead of Merck

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© Reuters. FILE PHOTO : An employee at Pfizer checks boxes containing Paxlovid and COVID-19 treatment drugs, in a Memphis distribution facility, Tennessee. This undated handout image shows the inspection. REUTERS/Pfizer

(Reuters) – The European Union’s Drug Regulator is about to make a decision on whether or not to approve Pfizer (NYSE)’s COVID-19 Pill at the End of This Month, prior to a final Merck review in February. Sources with knowledge said this.

Last year, the European Medicines Agency provided guidelines to member states about how to use antiviral and emergency medications. It also conducted rolling reviews in order to assist member states with quick approvals.

It is possible to buy the drug in several EU countries including Germany, Belgium and Italy.

Merck’s Pill, which was developed in collaboration with Ridgeback Biotherapeutics is being reviewed by the EMA. This is because Merck has released data from its trials that show it’s significantly less effective than originally thought.

Source said that while Merck applied earlier than Pfizer. However, Pfizer had submitted the final data regarding efficacy a little later and it therefore took European regulators more of a time to look at the last data.

Due to the confidentiality of EMA’s reviews, we are unable to identify this source.

Emer Cooke, EMA Executive Director, stated to RTE that the regulator might be able close its review of one antiviral this week. He also said that he was looking at a bit more on the second antiviral oral. This could push the topic into the next month’s discussions.

She didn’t identify the first drug that could be approved.

Antivirals are an important part of fighting the pandemic. However, the regulators are considering antivirals which are available at home to fight the Omicron strain.

The U.S. regulatory authorities and the UK have approved both drugs for certain high-risk adult patients.

On Jan. 10, the EMA stated that it might issue “within weeks” a decision whether or not to approve Pfizer’s two-drug combination Paxlovid.

It was almost 90% effective in preventing deaths and hospitalizations when administered early to high-risk patients with severe illnesses.

According to the source, the EMA would make its decision about Valneva’s VLA2001 COVID-19 candidate vaccine in March. This is in accordance with the French company’s timeline.

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