Press release
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> > > News Details EMA Issues Advice for Potential Early Use of Pfizer's Novel COVID - 19 Oral Antiviral Candidate 12/16/2021 : NEW YORK -- ( BUSINESS WIRE ) -- ( NYSE : PFE ) announced today that the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) issued advice on the use of PAXLOVID ™ ( nirmatrelvir [ PF - 07321332 ] tablets and ritonavir tablets ) , stating that PAXLOVID can be used to treat adults with COVID - 19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease . The CHMP also recommend that PAXLOVID should be administered as soon as possible after diagnosis of COVID - 19 and within five days of the start of symptoms . The EMA issued this advice under Article 5 ( 3 ) of Regulation 726/2004 to support authorities of European Union ( EU ) Member States who may decide to allow the supply and use of PAXLOVID , for example in emergency use settings , prior to EU conditional marketing authorization . PAXLOVID is currently not authorized for use in the EU . " The CHMP's advice signifies the strength of our data for PAXLOVID in the treatment of high - risk adults diagnosed with COVID - 19 , ” said Albert Bourla , Chairman and Chief Executive Officer , Pfizer . " COVID - 19 continues to take lives at an unprecedented pace globally and exacts a devastating toll on health care systems . If authorized , PAXLOVID has the potential to help save lives and reduce hospitalizations . We look forward to working with the EMA and other regulatory agencies worldwide to bring this potential treatment to patients as quickly as possible . " The CHMP based their advice on positive results from the Phase 2/3 EPIC - HR ( Evaluation of Protease Inhibition for COVID - 19 in High - Risk Patients ) interim analysis , which enrolled non - hospitalized adults with confirmed COVID - 19 who are at increased risk of progressing to severe illness . The data