Pfizer Inc (PFE)

[DewDiligence]

Paxlovid receives full-fledged FDA approval—with boxed warning for DDIs:

https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults

Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.

…Because of the importance of reducing the risk of significant drug-drug interactions with Paxlovid, the approved label and authorized Fact Sheet for Health Care Providers for the Paxlovid EUA come with a boxed warning with instructions for prescribers. Prescribers should review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines that a patient may be taking require a dose adjustment, interruption and/or additional monitoring. Prescribers should consider the benefit of Paxlovid treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed.

This FDA approval should enable ENTA to conduct a non-inferiority phase-3 trial of EDP-235 vs Paxlovid, as discussed in #msg-171965148.

EDP-235 does not have any significant drug-drug-interactions, so showing non-inferiority to Paxlovid on efficacy would be a big win for ENTA and its presumed EDP-235 partner.