Medical DevicesEuropean Medicines Agency Recommends First Marketing Authorisation For Cell-Based Medicine That Repairs Femoral Condyle Cartilage Defects
The European Medicines Agency has recommended the first marketing
authorisation for an advanced therapy medicinal product, following a
positive opinion from the Agency"s Committee for Advanced Therapies
(CAT) and the Committee for Medicinal Products for Human Use (CHMP).
ChondroCelect, from TiGenix NV, is a cell-based medicine that is used to
repair defects in the cartilage of the femoral condyle (the end of the
thighbone) in the knee. It consists of chondrocytes (cartilage-forming
cells) that are taken from a healthy region of the patient"s cartilage,
grown outside the body, and then re-implanted during surgery.
ChondroCelect is the first product to benefit from the new legal and
regulatory framework for advanced therapy medicinal products (Regulation
(EC) No 1394/2007). This framework is designed to ensure the free
movement of advanced medicines within the European Union (EU), to
facilitate their access to the EU market, and to foster the
competitiveness of European pharmaceutical companies in the field, while
guaranteeing the highest level of health protection for patients.
The CAT, a multidisciplinary committee bringing together some of the
best available experts in gene therapy, somatic cell therapy and tissue
engineering, assessed the scientific data provided to support the
marketing authorisation application for ChondroCelect. In line with the
procedure set out by the Regulation on advanced therapy medicinal
products, the CAT prepared a draft opinion, which was forwarded to the
CHMP. On the basis of this opinion, the CHMP adopted its recommendation
that ChondroCelect be granted marketing authorisation on 25 June 2009.
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 medicine"s efficacy and
safety are followed up in a robust manner once it is on the market.
The scientific recommendation will now be forwarded to the European
Commission for the adoption of a legally binding marketing authorisation
decision.
Notes
1. A summary of opinion for ChondroCelect with the full indication is
available
here.
2. The European Public Assessment Report (EPAR) for ChondroCelect with
detailed information on the scientific assessment of the medicine will
be published once the European Commission has adopted a marketing
authorisation decision.
3. More information about the Agency"s work in the field of advanced
therapy medicinal products can be found here.
4. A question-and-answer document on the regulation of advanced therapy
medicinal products is available here.
EMEA