February EMA/CHMP meeting results it eight new medicines backed for approval

At its February meeting, the European Medicines Agency’s human medicines committee CHMP recommended approval of eight novel medicines, one of which is a biosimilar.

The CHMP has recommended granting a marketing authorization for Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Akeega (niraparib/abiraterone acetate) for the treatment of metastatic castration-resistant prostate cancer with BRCA 1/BRCA 2 mutations. Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.

The committee adopted a positive opinion for Italian drugmaker Chiesi’s 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.