EU regulator to decide on Pfizer’s COVID-19 pill at the end of January

The European Medicines Agency (EMA), the European Union’s (EU) medicines regulator, is scheduled to decide whether to approve Pfizer’s COVID-19 pill later this month, before conducting a final review of the drug. similar but less effective Merck in February, according to a source with knowledge of the matter.

At the end of last year, the EMA provided guidance to Member States on the use of both antiviral pills as emergency treatments, while conducting ongoing reviews to help Member States decide on rapid adoption before any formal approval across the board. The EU.

Italy, Germany and Belgium are some of the EU countries that have bought these drugs.

The EMA’s review of Merck’s pill, developed with Ridgeback Biotherapeutics, is taking longer than Pfizer’s because Merck released trial data in November showing its drug was significantly less effective than previously thought. .

“Merck had submitted its application before Pfizer, but they submitted the final efficacy data later, so it took longer for European regulators to review that latest data,” the source said.

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

The EMA did not immediately respond to a request for comment.

While vaccines are critical to fighting the pandemic, regulators are looking at antivirals, which can be taken at home, as a new weapon against the rapidly spreading omicron variant.

Regulatory bodies in the United States and the United Kingdom have given both drugs the go-ahead to treat certain high-risk adult patients.

The EMA said on January 10 that it could issue a decision “in a few weeks” on the approval of the use of Paxlovid, Pfizer’s two-drug regimen.

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

The source also said that the EMA planned to issue its decision on the VLA2001 vaccine candidate. COVID-19 of Valneva in March, in line with the calendar given by the French company on January 6.