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Merck To Build Case For Doravirine-Based HIV Products On Efficacy, Safety Differences

 
• By Joseph Haas

Merck adds to its stagnating HIV portfolio with US approvals of doravirine and a three-drug combo including the NNRTI, but the combo’s potential may be limited due to inclusion of an older version of tenofovir.

Form close up, fountain pen and approved stamped on a document. Soft focus.

An ahead-of-schedule approval is always good news, but it’s unclear how much Merck & Co. Inc. will benefit from the US FDA nods for two news HIV therapies, novel non-nucleoside reverse transcriptase inhibitor (NNRTI) Pifeltro (doravirine) on its own and as part of the three-drug combination pill Delstrigo.

The two products obtained US FDA approval for treatment-naïve HIV-1-infected patients on Aug. 30, nearly two months ahead of their Oct. 23 user fee date

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