Regulatory News

EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda

The European Medicines Agency (EMA) on Friday recommended the approval of eight new medicines after its Committee for Medicinal Products for Human Use (CHMP) met to discuss the drugs earlier this week.

The agency also issued negative opinions for Nektar and Daiichi Sankyo's breast cancer drug Onzeald (etirinotecan pegol) and Vanda Pharmaceuticals' schizophrenia drug Fanaptum (iloperidone).

Among the eight new medicines are five orphan medicines, including Santen Pharmaceutical's Verkazia (ciclosporin), which was given an accelerated assessment for severe vernal keratoconjunctivitis.

The four other orphan medicines include:

• Pfizer's Bavencio (avelumab) to treat Merkel cell carcinoma;
• Novartis' Rydapt (midostaurin)  to treat acute myeloid leukemia, aggressive system mastocytosis, systemic mastocytosis with associated hematological neoplasm and mast cell leukemia;
• Lexicon Pharmaceuticals' Xermelo (telotristat ethyl) to treat carcinoid syndrome; and
• Advanced Accelerator Applications' nuclear medicine Lutathera (Lu-177 oxodotreotide) to treat gastro-entero-pancreatic neuroendocrine tumors, which was rejected by the US Food and Drug Administration late last year

In its negative opinion for Fanaptum, EMA said the drug showed only modest short-term effectiveness and raised heart safety concerns that were "not manageable by the risk-minimisation measures proposed by the company."

And, in its negative opinion for Onzeald, EMA said the benefit of the drug was not sufficiently proven, due to data from a subgroup analysis not being supported by additional studies.

The agency also issued positive recommendations for  Roche's Tecentriq (atezolizumab) in urothelial carcinoma and non-small cell lung cancer, Regeneron Pharmaceuticals' Dupixent (dupilumab) to treat atopic dermatitis and Janssen-Cilag's four-drug HIV combination Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide).

Other Recommendations

EMA also recommended generics for two drugs, including two copies of Bristol-Myers Squibb's hepatitis B drug Baraclude (entecavir) by Acord and Mylan, as well as Accord's copy of UCB's epilepsy drug Vimpat (lacosamide).

In addition, EMA recommended extending the indication of eight drugs, including Bydureon (exenatide), Gazyvaro (obinutuzumab), Humira (adalimumab), Keytruda (pembrolizumab), RoActemra (tocilizumab), Signifor (pasireotide), Sovaldi (sofosbuvir) and Vimpat.

EMA