Green light for new medicines

Emerging uses of EMA Approved Drugs – by Gary Finnegan – Several new medicines have been approved by the European Medicines Agency after recent meetings of its Committee for Medicinal Products for Human Use (CHMP).

These include a Forxiga (dapagliflozin), a new treatment for type 2 diabetes mellitus. There is a need for additional treatment options for type 2 diabetes mellitus, due to the increasing global prevalence of the disease, its progressive nature, which eventually requires combination therapy in most patients, as well as the fact that some patients may experience undesirable side effects from currently available therapies, the Agency said in a statement. .

Forxiga (dapagliflozin), from Bristol-Myers Squibb / AstraZeneca EEIG, is the first diabetes treatment to work by inhibiting the sodium‑glucose co‑transporter 2 (SGLT2), a transporter protein in the kidneys that allows glucose to be reabsorbed into the bloodstream.

Its mechanism of action allows improvement of glycaemic control in type 2 diabetes without increasing insulin secretion.

The CHMP also recommended that a license be granted to Novartis Europharm Ltd for Jakavi (5, 15, 20mg tablets) for the treatment of chronic idiopathic myelofibrosis and treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia.