From their meeting in May, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
May’s meeting saw eight medicines recommended for approval including a new vaccine for immunisation against the Ebola virus.
The new Ebola vaccine provides active immunity, and consists of two new medicines, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is administered as the first dose, with Mvabea eight weeks later as a booster. These medicines were evaluate under the EMA accelerated assessment pathway.
Marketing authorisations were recommended for Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus infection in adults with compensated liver disease, and Rozlytrek (entrectinib) for patients’ whose solid tumours have a neurotrophic tyrosine kinase gene fusion or ROS1-positive advanced non-small cell lung cancer. Piqray (alpelisib) for advance metastatic breast cancer with PIK3CA mutation and Xenleta (lefalumin) for community-acquired pneumonia in adults, also received positive opinions.
The biosimilar medicine Zercepac (trastuzumab) received a positive opinion for the treatment of breast and gastric cancer. Apixaban Accord (apixaban), a generic medicine, received a positive opinion for prevention of venous thromboembolic events, stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Furthermore, there were five recommendations for extensions of therapeutic indications, including Invokana, Lynparza, Ofev, Sivextro, and Taltz. However, applications for marketing authorisations for Erlotinib Accord (erlotinib) and Fingolimod Mylan (fingolimod) were withdrawn.
A detailed report of the meeting outcomes can be found here.