The latest set of opinions from advisors to the European Medicines Agency include recommendations to approve two hepatitis C and two psoriasis drugs, as well as therapies for idiopathic pulmonary fibrosis and Gaucher disease.
First up, the agency's Committee for Medicinal Products for Human Use has backed granting marketing authorisation for Sanofi’s Cerdelga (eliglustat) for Gaucher disease type 1, while Boehringer Ingelheim’s Ofev (nintedanib) will soon join Roche unit InterMune’s Esbriet (pirfenidone) on the market for IPF.
The CHMP was the bearer of good news for AbbVie with positive opinions for Exviera (dasabuvir) and Viekirax (ombitasvir/paritaprevir/ritonavir) for the treatment of chronic HCV. Both all-oral interferon-free treatments were reviewed under accelerated assessment and belong to a new generation of antivirals “that have high cure rates and have recently reshaped the treatment landscape for the disease”, the EMA noted.
There was also a boost for Celgene and Otezla (apremilast) which was recommended for both psoriatic arthritis and psoriasis itself. Novartis’ Cosentyx (secukinumab) has also just been backed for psoriasis (see link).
The committee also gave its backing to Shionogi’s Senshio (ospemifene) for vulvar and vaginal atrophy and Merck Sharp & Dohme’s Zontivity (vorapaxar) for the reduction of atherothrombotic events.
Among the other highlights of the CHMP’s monthly meeting was the decision to make HRA Pharma’s morning-after pill ellaOne (ulipristal acetate) available without the need for a prescription, starting in 2015.
Anna Glasier, a women’s reproductive health expert from the University of Edinburgh, noted that ellaOne “is a highly effective emergency contraceptive which we’ve been using for five years now, and making it more accessible and available more quickly from pharmacies is a logical and sensible thing to do”.