From their meeting in March, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced the recommendations for one new initial marketing authorisation and three extensions of indication.
A conditional marketing authorisation was recommended for Zynteglo (Autologous CD34+ cells encoding βA-T87Q-globin gene), which is an advanced therapy medicinal product (ATMP) for beta-thalassaemia, a rare inherited blood condition that causes severe anaemia. Zynteglo addresses an unmet medical need, therefore it benefited from support within the PRIME scheme. The PRIME scheme is EMA’s platform for early and enhanced dialogue with developers of promising new medicines.
Extensions of indication were recommended for Imnovid, Mozobil and Revlimid.
It was also confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are not effective in preventing further problems with the heart and blood vessels in patients who have had a heart attack.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.