TiGenix have announced that the company has received a positive opinion from the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on the European Marketing Authorisation application (MAA) for its lead product ChondroCelect.
ChondroCelect is a regenerative autologous medicinal product indicated for the repair of full thickness cartilage lesions of the knee. Clinical results demonstrated that ChondroCelect formed regenerated cartilage that was superior to the repair tissue obtained by microfracture, the current standard of care for cartilage defects in the knee. This was accompanied by a better clinical outcome and sustained clinical benefit to the patient.
The CHMP opinion for ChondroCelect will now be forwarded to the European Commission for adoption of the final community Marketing Authorisation, which is typically issued between 60 and 90 days from adoption of the CHMP opinion. The European Commission generally follows the advice of the CHMP. Upon approval, ChondroCelect will be the first cell based product to be centrally approved in the 27 member states of the European Union as well as in Iceland, Lichtenstein and Norway under the new Advanced-Therapy Medicinal Products (ATMP) legislation.
As part of the application the CAT and the CHMP have required the company to submit a risk management plan with a series of measures, including further studies to ensure that the
efficacy and the safety are followed up in a robust manner once in the market.
We are very proud on this achievement”, comments Wilfried Dalemans, Head of Regulatory Affairs of TiGenix. “Obtaining regulatory approval of the first ATMP product in Europe shows
that advanced cell therapy products can be developed according to the medicinal product regulatory requirements, and thus be made available to the patients in need of new
“The positive CHMP opinion is outstanding news for our company and is a great recognition for our entire team, that has worked very hard to achieve this important milestone.”
comments Gil Beyen, CEO of TiGenix. “We are ready and looking forward to launch ChondroCelect following the European Commission’s marketing authorisation and to
develop other regenerative medicine products for the joint.”