EMA recommended 35 new drugs in 2017

The European Medicines Agency (EMA) recommended approval for 35 new therapeutic agents last year, compared with 27 in 2016 and 39 in 2015.

The EMA's count includes small molecules, antibodies, biologics, blood products, cellular therapies and vaccines. As such, it cannot be compared directly with approvals from the FDA's Center for Drug Evaluation and Research (CDER), which reviews only small molecules and some types of biologic. (The FDA's CDER had a standout year for approvals in 2017; see page 81.) There is nevertheless considerable overlap in the new drug lists, including approvals for blockbuster contenders such as Regeneron and Sanofi's interleukin-4 receptor subunit-α antagonist dupilumab for atopic dermatitis, Roche's anti-CD20 ocrelizumab for multiple sclerosis and Novo Nordisk's GLP1 receptor agonist semaglutide for type 2 diabetes.

The EMA gave green lights to several drugs that have not yet been approved in the US. For example, it recommended Ultragenyx's anti-FGF23 antibody burosumab for X-linked hypophosphataemia. This antibody is currently under review at the FDA for possible approval by May. The EMA also gave a thumbs up to Dompé's recombinant human nerve growth factor oxervate, for neurotrophic keratitis. Dompé has initiated a rolling submission to get FDA approval of this drug.

The EMA also recommended approval for TiGenix and Takeda's darvadstrocel, for complex perianal fistulas in patients with Crohn's disease. This product is the first donor-derived 'off-the-shelf' stem cell therapy to gain approval in the European Union. The sponsors have yet to disclose a US filing timeline for this product.