EMA Recommends 13 Drugs for Approval

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The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.

On April 26, 2019, the European Medicines Agency announced that its Committee for Medicinal Products for Human Use (CHMP) had recommended approval for 13 new medicines. Marketing authorization was recommended for treatments of opioid dependence, HIV, breast cancer, among others. Two orphan drugs were also approved.

CHMP approved Esperoct (turoctocog alfa pegol), an orphan drug, for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency). Ultomiris (ravulizumab), also an orphan drug, was approved for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

New cancer treatments that were recommended included Talzenna (talazoparib), for the treatment of adult patients with germline BRCA1/2 mutations who have HER2-negative locally advanced or metastatic breast cancer, and the biosimilar Grasustek (pegfilgrastim) for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy. Libtayo (cemiplimab) received conditional marketing authorization for the treatment of advanced cutaneous squamous cell carcinoma.

Positive opinions were given by CMHP for Doptelet (avatrombopag), for the treatment of severe thrombocytopenia, and Dovato (dolutegravir/lamivudine), for the treatment of HIV infection. Sixmo (buprenorphine) was granted marketing authorization as a substitution treatment for opioid dependence. Sixmo, an implant, releases low levels of buprenorphine into the patient’s body for six months.

Two generic medicines were also approved: Ambrisentan Mylan (ambrisentan), for the treatment of pulmonary arterial hypertension, and Striascan (ioflupane (123I)), a radiopharmaceutical to diagnose Parkinson’s disease and other related diseases and dementia.


Nuceiva (botulinum toxin type a) was approved as a temporary improvement of severe vertical lines between the eyebrows that have a psychological impact in adults below 65 years of age.

The hybrid medicine Xromi (hydroxycarbamide) was given positive opinion by CMHP for the prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age. According to EMA, “hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorized reference product and in part on new data.”

Positive opinion was also given to Temybric Ellipta (fluticasone furoate/umeclidinium/vilanterol), an informed consent application for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease. According to EMA, “an informed consent application makes use of data from the dossier of a previously authorized medicine, with the marketing authorization holder of that medicine giving consent for the use of their data in the application.”

Source: EMA