EMA recommends Boehringer/Lilly's Tradjenta, Novartis' Votubia and Sigma-Tau's Eurartesim; updates on pioglitazone

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday recommending approval of German independent drugmaker Boehringer Ingelheim and US partner Eli Lilly’ (NYSE:LLY) linagliptin, 5mg, film-coated tablets (to be marketed under the trade name Tradjenta in Europe) for the treatment of adults with type 2 diabetes. Tradjenta recently gained Food and Drug Administration approval and roll out of the drug in the USA began earlier this month (The Pharma Letter June 16).

If adopted by the European Commission, linagliptin will be the only DPP-4 inhibitor approved at one dosage strength for patients with type 2 diabetes in Europe. The CHMP has recommended the approval of linagliptin as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. Linagliptin is also recommended for approval in combination with metformin and metformin plus sulfonylurea. Data showed linagliptin plus metformin reduced hemoglobin A1C (HbA1C or A1C) levels by a mean of 0.6% to 0.7% (compared to placebo).

Votubia recommended for SEGA