The latest set of opinions from the European Medicines Agency includes recommendations for Vertex Pharmaceuticals' cystic fibrosis treatment, Almirall's chronic obstructive pulmonary disease drug and a new cancer therapy from Pfizer.
First up, the agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of Vertex' Kalydeco ((ivacaftor), a first-in-class medicine for patients aged six and older who have the specific G551D mutation in the CF transmembrane regulator gene. The CHMP, which reviewed the drug under accelerated assessment (in 150 days) noted that Kalydeco, approved in the USA in January, "is the first treatment that targets the underlying mechanism of the disease, by restoring the function of the mutated CFTR protein."
A positive opinion has also been issued for Almirall's aclidinium bromide, which will be sold as Eklira and Bretaris. The treatment is a long-acting antimuscarinic for the maintenance treatment of COPD and will compete Boehringer Ingelheim's blockbuster Spiriva (tiotropium), which is marketed by Pfizer.
There were also recommendations for Eisai's epilepsy drug Fycompa (perampanel) and Novo Nordisk's NovoThirteen (catridecacog) for the treatment of bleeding in patients six years and above with congenital factor XIII A-subunit deficiency. The CHMP also gave its backing for Pfizer's Inlyta (axitinib) as a treatment for advanced renal cell carcinoma after the failure of treatment with the drug giant's own Sutent (sunitinib) or with cytokines.
Approval has also been recommended for Boehringer Ingelheim's diabetes drug Jentadueto, which combines metformin with the DPP-4 inhibitor Tradjenta (linagliptin), which is partnered with Eli Lilly.