Six medicines recommended for approval, including one orphan

The European Medicines Agency’s Committee for Medicinal Products for Human Use(CHMP) recommended six medicines for approval at its February meeting.

The CHMP recommended granting a conditional marketing authorisation for Natpar (parathyroid hormone) as a treatment for patients with chronic hypoparathyroidism who cannot be adequately controlled with standard treatment with calcium and vitamin D. Natpar has an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia.

Varuby (rolapitant) was recommended for approval by the Committee for the prevention of nausea and vomiting.

The CHMP granted a positive opinion for one informed consent application: Roteas (edoxaban) for the prevention of stroke and systemic embolism in adults with atrial fibrillation, and for the treatment and prevention of deep vein thrombosis and pulmonary embolism. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Two generic medicines received a positive opinion from the Committee: Emtricitabine / Tenofovir disoproxil Krka d.d. (emtricitabine / tenofovir disoproxil) for the treatment of HIV infection and Pemetrexed Hospira UK Limited (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.

Four recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Darzalex, Mekinist, Tafinlar and Truvada.

Outcome of review on SGLT2 inhibitors

The CHMP is informing patients and healthcare professionals of a potential increased risk of lower limb amputation (mostly affecting the toes) in patients taking the SGLT2 inhibitors canagliflozin, dapagliflozin and empagliflozin used for type 2 diabetes. Patients taking these medicines are reminded to check their feet regularly and follow their doctor’s advice on routine preventative foot care. They should also tell their doctor if they notice any wounds or discoloration, or if their feet are tender or painful. For more information please see the public health communication in the grid below.

Posted on the EMA website on 24 February 2017