Vertex has won a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its triple combination cystic fibrosis therapy, alongside a host of other recommendations announced in the Committee’s June meeting.
The CHMP has recommended granting a conditional marketing authorisation for the triple therapy, comprised of elexacaftor/tezacaftor/ivacaftor, under the brand name Kaftrio. It is the first triple combination therapy for the treatment of CF in patients aged 12 years and older with one F508del mutation and one minimal function mutation and in patients with two F508del mutations.
The triple therapy was approved by the US Food and Drug Administration (FDA) in October last year, and scored that approval only a few months after filing the combination treatment with the agency. In the US, the drug was approved under the brand name Trikafta, and priced at $311,000 for a year of treatment.
The treatment provides a new treatment option for many CF patients, including for those with certain mutations where no treatment is currently available in the EU.
Read more: http://www.pmlive.com/pharma_news/vertexs_triple_cf_therapy_scores_recommendation_from_chmp_1343261