EMA greenlights new medicines

With the three innovative medicines and four generics the number of recommended medicines raised to 47 in 2019.

The Committee saw a positive benefit to risk ratio for Xospata (gilteritinib), a FLT3 kinase blocker developed by Astellas Pharma Europe BV, to treat adults suffering from the orphan blood cancer relapsed/refractory acute myeloid leukaemia (AML), whose FLT3 gene is mutated. AML is estimated to affect one in 10,000 people in the European Union. Xospata was reviewed under the EMA’s accelerated assessment procedure.

The CHMP issued a positive opinion on AstraZeneca AB’s Qtrilmet (metformin hydrochloride / saxagliptin / dapagliflozin) for the treatment of type 2 diabetes mellitus.

Finally the EMA committee recommended granting a marketing authorisation for Rhokiinsa (netarsudil) eye drops, Aerie Pharmaceuticals Ireland Ltd’s  rho kinase inhibitor for the treatment of patients with glaucoma or ocular hypertension.