Pfizer’s PARP inhibitor, Talzenna (talazoparib), has been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for adults with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, heading up April’s recommendations list.
Thirteen medicines were recommended for approval at the Committee’s April 2019 meeting, including two orphan medicines; Novo Nordisk’s Esperoct (turoctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A; and Alexion’s Ultomiris (ravulizumab), for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.
Also of particular note, this month saw recommendation of L. Molteni & C. dei Fratelli Alitti Società di Esercizio's Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months. It is indicated in clinically stable adult patients who require no more than 8 mg per day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Elsewhere, Dova Pharma received a positive opinion for Doptelet (avatrombopag) for the treatment of severe thrombocytopenia and GlaxoSmithKline for Dovato (dolutegravir/lamivudine), for the treatment of HIV infection.
The Committee recommended the granting of a conditional marketing authorisation for Sanofi’s Libtayo (cemiplimab), for the treatment of advanced cutaneous squamous cell carcinoma and adopted a positive opinion for Evolus’ Nuceiva (botulinum toxin type a), intended for temporary improvement of vertical lines between the eyebrows, when the severity of the facial lines has an important psychological impact in adults below 65 years of age.
USV’s biosimilar, Grasustek (pegfilgrastim), received a positive opinion for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy and two generic medicines were recommended for marketing authorisation grants – Mylan’s Ambrisentan Mylan (ambrisentan) and CIS BIO International’s Striascan (ioflupane) - a generic of DaTSCAN.
Rounding up the decisions are a positive opinion for Nova Laboratories’ Xromi (hydroxycarbamide) for sickle cell disease complications and another GSK drug, Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol), for adults with chronic obstructive pulmonary disorder (COPD).
Speaking of the Talzenna recommendation, Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development, said: “There is a pressing need for new, effective medicines that are specifically developed for patients with an inherited BRCA mutation who are often diagnosed at a younger age and have limited options for the treatment of advanced-stage disease. Results from the Embraca trial provide evidence supporting the use of Talzenna in these patients, and we look forward to working with the European Commission to potentially offer an alternative treatment option to chemotherapy.”