Six medicines have taken a giant leap toward winning approval in Europe having won the backing of the European Medicines Agency’s (EMA) human medicines committee (CHMP).
The recommendations include a positive opinion for Teva’s Ajovy (fremanezumab), an injectable prescription medicine used to prevent migraine headaches in adults that works by blocking the activity of calcitonin gene-related peptide (CGRP).
Other positive opinions included Pfizer’s Vizimpro (dacomitinib) – for the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor activating mutations, and two biosimilar medicines made by Fresenius Kabi Deutschland – Idacio (adalimumab) and Kromeya (adalimumab), for the treatment of certain inflammatory and autoimmune disorders.
The CHMP also recommended granting marketing authorisations for KRKA’s Atazanavir Krka (atazanavir), a treatment for HIV-1 infection in adults and children six years of age and older, and Febuxostat Krka (febuxostat), for the prevention and treatment of hyperuricaemia.
On the other hand, TLC Biopharmaceuticals’ Doxolipad (doxorubicin), a cancer medicine that contains the active substance doxorubicin, received a negative opinion. Doxolipad was intended to be similar to a reference medicine already authorised in the European Union called Adriamycin.
According to the Committee, the results of the bioequivalence study showed that Doxolipad is comparable to Caelyx in terms of liposome-encapsulated doxorubicin’, but failed to show that the amount of ‘free doxorubicin’ is the same for the two medicines.
“Therefore, the CHMP was of the opinion that there was insufficient evidence to show that Doxolipad was bioequivalent to Caelyx, and it was not possible to establish that the benefits of Doxolipad outweigh its risks. On that basis, the CHMP recommended that Doxolipad be refused marketing authorisation.”
Nine extensions of therapeutic indication were also recommended, spanning Edistride, Forxiga, Hemlibra, Keytruda, Mabthera, Maviret, Orencia, Praluent and Tecentriq.
