Only three new meds recommended for approval at April EMA/CHMP meeting

27 April 2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended three medicines for approval at its April 2018 meeting.

The CHMP recommended granting a marketing authorization for Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), from US biotech Gilead Sciences (Nasdaq: GILD), for the treatment of HIV-1 infection, in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.

If approved, Biktarvy would be the fifth TAF-based product for HIV in the European Union in the past three years, and because of its drug interaction profile, minimal monitoring requirements and ease of administration we believe it could represent a meaningful advance in HIV treatment for appropriate patients in Europe, according to Gilead.

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