Europe – EMA: Thumbs up for 11, down for 2 new medicines

At its June 2020 meeting, the human medicines committee of the European Medicines Agency (EMA’s CHMP) recommended that 11 new medicines be approved for use in the European Union (EU); one of these, Dapirivine Vaginal Ring, was recommended under EU Medicines for All, a mechanism for medicines that are also to be used outside the EU.

Dapirivine Vaginal Ring is meant to reduce the risk of infection with HIV, in situations where oral pre-exposure prophylaxis is not used, cannot be used, or is unavailable. The active antiretroviral ingredient, dapirivine, is released over 28 days.

The committee also gave out its second and third negative recommendations of the year for Elzonris (tagraxofusp) and Gamifant (emapalumab). Gamifant’s use was to be treatment of primary hemophagocytic lymphohistiocytosis, a genetic disease; Elzonris was to be used to treat blastic plasmacytoid dendritic cell neoplasm, a variant of acute myeloid leukemia.

In both instances, CHMP cited the small sample size of the studies upon which the submissions relied, noting that both efficacy and safety were difficult to determine in such small samples. In addition, for Gamifant, the committee observed that the reliability of study data could not be confirmed…