Johnson and Johnson's experimental two-stage vaccine for protection against Ebola virus disease is among eight medicines backed by the European Medicines Agency's human medicines committee (CHMP) at its May meeting.
The vaccine, developed by J&J group Janssen, provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged one year and older.
It consists of two components, Zabdeno (Ad26.ZEBOV), which is given first, and Mvabea (MVA-BN-Filo), given around eight weeks later.
Zabdeno and Mvabea received a positive opinion for marketing authorisations under exceptional circumstances 'because the applicant was able to demonstrate that it is not possible to conduct a randomised controlled study that might generate comprehensive clinical data on the efficacy of the new Ebola vaccine even after authorisation', the agency noted.
Elsewhere, the following medicines also took giant leap closer to EU approval:
- MYR's Hepcludex (bulevirtide), for the treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease. Because there are no treatments currently approved for hepatitis D;
- Novartis' Piqray (alpelisib) for the treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation.
- Roche's Rozlytrek (entrectinib; conditional marketing authorisation), for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer;
- Nabriva Therapeutics Ireland's Xenleta (lefamulin) for the treatment of community-acquired pneumonia in adults;
- Accord Healthcare's biosimilar Zercepac (trastuzumab) for the treatment of breast and gastric cancer; and
- Accord's generic Apixaban Accord (apixaban) for treatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.