European Medicines Agency
EMA recommends seven new medicines for approval across the EU
Two orphan drugs are among the medicinal products given the green light by the European Medicines Agency.
Seven new medicines are being recommended for approval for use across the European Union following the latest meeting of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The committee agreed a new marketing authority for the advanced therapy medicinal product darvadstrocel (Alofisel) — which has an orphan designation — for the treatment of complex perianal fistulas in patients with Crohn’s disease.
A paediatric-use marketing authorisation was granted for the hydrocortisone Alkindi, for the treatment of the rare disorder primary adrenal insufficiency.
A conditional marketing authorisation for burosumab (Crysvita) — which has orphan drug designation — for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children and adolescents with growing skeletons was also recommended for approval.
Semaglutide, marketed as Ozempic, received a positive opinion for the treatment of type 2 diabetes.
The biosimilar trastuzumab (Herzuma), for the treatment of breast and gastric cancer, was also recommended for approval.
Two generic medicines received a positive CHMP opinion: anagrelide (Anagrelide Mylan) for the reduction of elevated platelet counts in at-risk essential thrombocythaemia patients, and efavirenz/emtricitabine/tenofovir disoproxil (Efavirenz/Emtricitabine/Tenofovir disoproxil Krka) for the treatment of HIV infection.
But the committee reached a negative opinion for the new medicine plitidepsin, branded as Apilidin, which was seeking approval for the treatment of patients with multiple myeloma.
The committee also reported the findings of its safety review of mycophenolate medicines, which are taken to prevent the rejection of transplanted organs.
According to current evidence there is no risk of malformation to the foetus or miscarriage in pregnant women if their male partner takes these drugs, it concluded.
However, it felt that the risk could not be completely ruled out and recommended that either the male patient or female partner use reliable contraception.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20204162
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