Meeting highlights from the CHMP meeting in February 2017
Six medicines recommended for approval, including one orphan
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended six medicines for approval at its February 2017 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.
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
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
CHMP has adopted recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC) for diabetes medicines canagliflozin, dapagliflozin and empagliflozin. These medicines belong to the SGLT2 inhibitors group, and the recommendations refer to a potential increased risk of lower limb amputation (mostly affecting the toes). 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.
More information is available on HALMED's website.
More information on CHMP's February 2017 meeting is available on EMA's website.