EMA’s human medicines committee (CHMP) recommended six medicines for approval at its January 2019 meeting.
The CHMP adopted a positive opinion for Ajovy (fremanezumab), for the prophylaxis of migraine.
Vizimpro (dacomitinib) received a positive opinion for the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor activating mutations.
Two biosimilar medicines for the treatment of certain inflammatory and autoimmune disorders received a positive opinion from the Committee: Idacio (adalimumab) and Kromeya (adalimumab).
The CHMP recommended granting marketing authorisations for two generic medicines: Atazanavir Krka(atazanavir), for the treatment of HIV-1 infection in adults and children 6 years of age and older, and Febuxostat Krka (febuxostat), for the prevention and treatment of hyperuricaemia.
The CHMP adopted a negative opinion refusing a marketing authorisation for Doxolipad (doxorubicin). The Committee recommended extensions of indication for Edistride, Forxiga, Hemlibra, Keytruda, Mabthera, Maviret, Orencia, Praluent and Tecentriq.
The CHMP recommended an extension of indication of Forxiga and its duplicate Edistride to include for the first time adjunct treatment with insulin for certain patients with type 1 diabetes.
