Posted by Michael Wonder on 29 Mar 2019
Highlights from CHMP 25-28 March 2019 meeting
29 March 2019 - EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions of indication at its first meeting in Amsterdam in March 2019.
The Committee recommended granting a conditional marketing authorisation for Zynteglo (Autologous CD34+ cells encoding βA-T87Q-globin gene), an advanced therapy medicinal product (ATMP) for beta-thalassaemia, a rare inherited blood condition that causes severe anaemia. Zynteglo is intended for adult and adolescent patients 12 years and older who need regular blood transfusions to manage their disease and have no matching donor for a stem cell transplant.
Since Zynteglo addresses an unmet medical need, it benefited from support within the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines. This interaction led to a more robust application package which allowed accelerated assessment of Zynteglo in 150 days, the fastest review time for an ATMP to date.
