- The European Medicines Agency on Thursday took the unusual step of telling EU member countries they may authorize early use of Pfizer's experimental COVID-19 pill Paxlovid while the regulator continues its review of the antiviral medicine.
- In a statement, the EMA said Paxlovid could be used to treat adults with COVID-19 who are at high risk of severe symptoms. The regulator, which has not authorized Paxlvoid and just started its review this week, cited quickly rising COVID-19 cases and deaths across Europe as the basis for its preliminary advice.
- EU member states can use the EMA's advice as support for national-level authorizations of Paxlovid, according to the agency, which plans to soon publish further guidelines for early use of the pill
On Monday, Pfizer released final results from a large clinical trial of Paxlovid, confirming earlier, preliminary data that had shown a dramatic benefit from the pill.
According to the company's Dec. 14 statement, treatment with Paxlovid cut the risk of hospitalization or death from COVID-19 by about 90% compared to a placebo, when given within five days of symptoms beginning. Promising early results for another pill developed by Merck & Co. had faded on further analysis, so Pfizer's finding was an reassuring sign its drug could live up to the high expectations set for it.
The emergence and rapid spread of the omicron variant, meanwhile, has made a convenient treatment that can stave off COVID-19's worst effects even more critical — a fact reflected in the EMA's out-of-sequence recommendation.
"EMA issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorization, for example in emergency use settings, in the light of rising rates of infection and deaths due to COVID-19 across the EU," the regulator said in a statement.
Paxlovid is taken together with another medication called ritonavir that slows metabolization of the drug, thereby prolonging its effects.
The EMA cautioned against use of Paxlovid during pregnancy or in people who can become pregnant and aren't using contraception, citing the potential risks the drug could pose to a fetus.
In the U.S., the Food and Drug Administration is currently reviewing the drug and is expected to make a decision soon. A verdict from the agency on Merck's oral coronavirus drug molnupiravir is anticipated as well after an outside panel of experts voted 13-10 in favor of authorizing it for emergency use.
It's not clear how much supply of Paxlovid would be available to any EU country that decides to use the EMA's advice in support of an emergency clearance.