EMA’s CHMP recommends three new medications

pharmafile | September 23, 2019 | News story | Sales and Marketing  

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) have recommended approval for three new medicines with AstraZeneca securing approval from regulators to market its Qtrilmet tablets for the treatment of type 2 diabetes.

The AZ approval was based on five phase 3 trials which evaluated combination of Forxiga (dapagliflozin), Onglyza (saxagliptin) and metformin patients with inadequately-controlled type 2 diabetes. Qtrilmet is a combination of these three drugs.

Across the trials, the combination of Forxia, Onglyza and metformin was superior in reducing average blood glucose levels versus Forxiga combined with metformin.

Qtrilmet is already approved in the US under the name Qternmet XR as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

Another medication recommended by the CHMP were Astellas’ acute myloid leukemia drug Xospata (gliteritinib) which was granted orphan designation and reviewed under the EMA’s accelerated access scheme. The recommendation comes less than a year after the US FDA approved Xospata in the same indication.

The third drug is Aaeerie Pharmaceuticals’ Rhokiinsa (netarsudil) for the treatment of glaucoma and ocular hypertension.

The CHMP also recommended the authorisation of three generic medicines, including arsenic trioxide, bortezomib, and Ivozall (clofarabine).

Nik Kiran

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