Seven new meds recommended for approval, including one orphan, by EMA/CHMP

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting.

A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission, which is usually forthcoming within two or three months.

The CHMP recommended granting a marketing authorisation for Hemlibra (emicizumab), from Swiss pharma giant Roche (ROG: SIX), a first-in-class medicine to prevent bleeding episodes in patients with hemophilia A who have factor VIII inhibitors. This medicine was reviewed under EMA’s accelerated assessment procedure, reserved for medicines of major public health interest.

The CHMP recommended granting a marketing authorisation for Lamzede (velmanase alfa), from Italy’s Chiesi Farmaceutici, a long-term enzyme replacement therapy in adults, adolescents and children with non-neurological manifestations of mild to moderate alpha-mannosidosis. Because alpha-mannosidosis is a very rare disease, Lamzede was granted an orphan designation. There is currently no cure for this disease. Patients with the less severe forms of the disease are managed with supportive care including symptom management, medical and surgical treatment of complications and physical therapy.

The Committee recommended granting a marketing authorization for Shingrix (recombinant, adjuvanted Herpes zoster vaccine), from UK pharma major GlaxoSmithKline (LSE: GSK), a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in adults 50 years of age or older.

The CHMP gave positive opinions for three medicines to treat type 2 diabetes from US pharma giant Merck & Co (NYSE: MRK): Segluromet(ertugliflozin/metformin), Steglatro (ertugliflozin) and Steglujan(ertugliflozin/sitagliptin).

One biosimilar medicine was recommended for approval by the Committee: Semglee (insulin glargine), from Netherlands-incorporated Mylan (Nasdaq: MYL), for the treatment of diabetes. The originator drug is Sanofi’s Lantus.


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