The European Medicines Agency’s human medicines committee (CHMP) has put forward seven medicines for approval in the region.
The Committee backed clearance of two orphan medicines: OP Orphan Pharmaceuticals’ Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly; and medac’s Trecondi (treosulfan), for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation.
Shionogi’s Lusutrombopag Shionogi (lusutrombopag) was endorsed as a treatment for severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures, and the firm’s Rizmoic (naldemedine) for the treatment of opioid-induced constipation.
A green light was also issued for PARI Pharma’s Tobramycin PARI (tobramycin), a hybrid medicine (which rely in part on the results of preclinical tests and clinical trials of a reference product and in part on new data) for management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged six years and older with cystic fibrosis.
Pfizer’s Avastin biosimilar Zirabev (bevacizumab) was granted a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer and carcinoma of the cervix, while the Committee also recommended approval of Dipharma’s generic Miglustat Dipharma (miglustat), for the treatment of adult patients with mild to moderate type 1 Gaucher disease.