Six new medications have come significantly closer to European approvals having won the backing of the European Medicines Agency (EMA) human medicines committee (CHMP).
The positive opinions come for Teva’s Ajovy (fremanezumab), an injectable medication for the prevention of migraine in adults. Additionally Pfizer’s Vizimpro (dacomitinib) for locally advanced or metazoic non-small cell lung cancer was given a green light.
Further down the list are positive opinions for Idacio (adalimumab) and Kromeya (adalimumab) belonging to Fresenius Kabi Deutschland. These injectables will carry indications for rheumatoid arthritis, juvenile idiopathic arthritis, axial sponyloarthritis, psoriasis, ulcerative colitis as well as Crohn’s disease in adults and children. Idacio will have the same indications including one for hidradenitis suppurative, a painful and long-term skin condition in adults and children.
The CHMP also recommended granting marketing authorisation for KRKA’s Atazanavir Krka (atazanavir), a treatment for HIV-1 infection in adults and children aged over six.
Finally Febuxostat Krka (febuxostat) was also recommended in being given marketing authorisation for the treatment and prevention of hyperurcicaemia, a condition involving excessive uric acid in the bloodstream.
On the flip side, TLC Biopharmaceuticals’ Doxolipad (doxorubicin) was given a negative opinion in the treatment of cancer because of insufficient evidence.
The CHMP also extended therapeutic indications for nine medications – Forxiga, Keytruda, Mabthera, Orencia, Maviret, Tecentriq, Edistride and Praluent.