In what proved to be one of the busiest meeting of the year so far, advisors to the European Medicines Agency have recommended approval for 10 new medicines.
Sanofi/Genzyme's monoclonal antibody Lemtrada (alemtuzumab) was given the thumbs up for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
The positive opinion was based on data from the CARE-MS I and CARE-MS II trials, in which Lemtrada - which has a novel dosing/administration schedule of two treatment courses a year - was significantly more effective than Rebif (subcutaneous interferon beta-1a 44mcg three times weekly) at reducing relapse rates, according to Genzyme.
Also, accumulation of disability was significantly slowed in patients taking the drug versus Rebif and, crucially, Lemtrada-treated patients were significantly more likely to experience improvement in pre-existing disabilities.
The most common adverse events linked with Lemtrada were infusion-associated reactions, including headache, rash, fever, nausea and hives and, while the incidence of serious adverse events was similar between the two treatment arms, autoimmune disorders were more frequent in patients treated Genzyme's drug, the group said.
Elsewhere, three medicines to treat cancer received positive CHMP opinions.
Perhaps most notably, Dendreon's Provenge (sipuleucel-T), a cell-based therapy for the treatment of metastatic castrate-resistant prostate cancer, became the fourth advanced therapy medicinal product to be recommended.
GlaxoSmithKline's Tafinlar (dabrafenib) for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation, and Bayer's Stivarga (regorafenib) for the treatment of metastatic colorectal cancer, were also given the thumb's up for approval.
Other positive recommendations included: Raptor's orphan drug Procysbi (cysteamine bitartrate) for the management of the rare genetic disease cystinosis; Abbott's Cholib (fenofibrate/simvastatin) as adjunctive therapy to diet and exercise to reduce triglycerides and increase HDL-cholesterol in adults with mixed dyslipidaemia with high cardiovascular risk; AstraZeneca's Nexium Control (esomeprazole) for the short-term treatment of reflux symptoms in adults; and Omrix' Evarrest (human fibrinogen/thrombin) for haemostats.
Marketing authorisations for the first two monoclonal antibody biosimilars - Remsima and Inflectra - were also endorsed; these have been covered in more detail a separate PharmaTimes World News article.
