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Pfizer Obtains CHMP Positive Opinion For COVID-19 Oral Treatment

The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA issued a positive opinion recommending the conditional marketing authorization of Pfizer Inc.'s (PFE) Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.

If authorized, Paxlovid will be the first COVID-19 oral treatment recommended in the European Union. The European Commission decision on conditional marketing authorization is expected imminently.

The CHMP based its positive opinion on the scientific evidence supporting Paxlovid, including data from the Phase 2/3 EPIC-HR. The data showed that Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo, with no deaths observed in the treatment group, the company said in a statement.

Paxlovid is currently approved or authorized for emergency use in more than 10 countries across the globe.

Paxlovid is administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of Paxlovid, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

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