The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed seven new medicines for approval at its December meeting, bringing the total number recommended during the year to 81, dropping from 2015's tally of 93.
Eli Lilly's Olumiant (baricitinib) was put forward as an oral treatment for moderate to severe active rheumatoid arthritis, offering patients who have not responded adequately to, or who are unable to tolerate one or more disease‑modifying anti-rheumatic drugs (DMARDs) a new treatment option.
The drug works by blocking the action of Janus kinases (JAKs), enzymes that play an important role in the process of immunity and inflammation that occurs in the disease; its approval would mark the first JAK inhibitor to be used to treat RA in the EU, giving a different mode of action to what is currently available.
The CHMP also recommended a conditional marketing authorisation for Roche's Alecensa (alectinib) for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Objective response rates of 50.8 percent and 52.2 percent (in the evaluable population) were observed in two Phase II studies, while the the median duration of response was 15.2 and 14.9 months and median progression free survival 8.9 and 8.2 months, the CHMP noted.
Pfizer's tumour necrosis factor alpha (TNF-α) inhibitor Lifmior (etanercept) also received a positive recommendation, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis.
Also receiving CHMP backing: Celltrion Healthcare Hungary's rituximab biosimilar Truxima for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis; Actelion's hybrid medicine Ledaga (chormethine) for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma, (hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data); and Zentiva's generic pregabalin for the treatment of epilepsy, neuropathic pain and generalised anxiety disorder.
The CHMP also issued a positive opinion for the informed consent application (where the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure) for Octapharma's Vihuma (simoctocog alfa) for the prevention and treatment of bleeding in patients with haemophilia A.