EMA recommends nine drugs for market approval

Two orphan medicines received a positive opinion from the CHMP. Novo Nordisk’s recombinant Factor VIII replacement therapy Esperoct (turoctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients above 12 years adds another haemophilia A treatment to the crowed hemophilia market. Alexion Europe SAS’ Ultomiris (ravulizumab) is an anti-C5-blocking long-acting humanised antibody blocking the complement cascade for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

Futhermore, the Committee recommended to grant a marketing authorisation for Sixmo (buprenorphine), which will be offered as medical implant releasing the partial opiod agonist/antagoist buprenorphine over six months as a substitution treatment for opioid dependence.

Also, Dova Pharmaceuticals Ireland Ltd received a positive opinion for Doptelet (avatrombopag) to treat severe thrombocytopenia in patients with chronic liver disease facing an invasive procedure. The small molecule thrombopoietin receptor agonist  stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in increased production of platelets thus reducing the need for platelet transfusions before a scheduled invasive procedure or for rescue therapy for bleeding during the 7 days after the procedure. 

Furthermore, the CHMP adopted a positive opinion for ViiV Healthcare BV’s Dovato (dolutegravir / lamivudine), for the treatment of HIV infection.

Regeneron’s PD-1 blocker Libtayo (cemiplimab) was recommended by the CHMP to receive a conditional marketing authorisation for the treatment of advanced cutaneous squamous cell carcinoma. Pfizer’s Talzenna (talazoparib) received a positive opinion for the treatment of patients with germline BRCA1/2 mutations who have HER2-negative locally advanced or metastatic breast cancer.

The CHMP also recommended granting market approval to the pegylated G-CSF biosimilar medicine Grasustek (pegfilgrastim) from Juta Pharma GmbH for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy.