Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended granting a marketing authorisation for Akeega (niraparib/abiraterone acetate) for the treatment of metastatic castration-resistant prostate cancer with BRCA 1/BRCA 2 mutations.

The committee adopted a positive opinion for Elfabrio* (pegunigalsidase alfa) for the treatment of Fabry disease, a rare genetic disorder that results from the build-up of a type of fat in the body cells.

Hyftor* (sirolimus) received a positive opinion from the CHMP for the treatment of facial angiofibroma, a benign vascular skin lesion composed of dermal fibrous tissue and blood vessels. Hyftor is indicated for the treatment of adults and children above six years of age.

The CHMP adopted a positive opinion for Opzelura (ruxolitinib) for the treatment of non-segmental vitiligo, a skin disorder characterised by depigmented patches of skin. Opzelura is indicated for the treatment of adults and adolescents from…