Approval of combined Advanced Therapy Product

With the press release dated from 26 April 2013 the European Medicines Agency (EMA) recommends the approval of a combined advanced-therapy product. MACI (matrix-induced autologous chondrocyte implantation) is a product of  Genzyme and is for the repair of symptomatic, full-thickness cartilage defects of the knee of 3-20 cm2 in skeletally mature adult patients. MACI uses a scaffold formed of porcine collagen on which autologous chondrocytes are seeded. At implantation, the scaffold is trimmed to the size and shape of the cartilage defect. The cells/collagen structure is held in place in the lesion with fibrin glue.

After the evaluation of MACI by the Agency’s Committee for Advanced Therapies (CAT) and their positive opinion for the approval and the following agreement of the Committee for Medicinal Products for Human Use (CHMP), the CHMP's opinion on MACI will now be sent to the European Commission for adoption of a marketing-authorisation decision.

MACI was already authorised in certain EU countries before the regulation came into force. However, in order to comply with the European legislation on ATMPs it had to be evaluated through the centralised procedure. MACI has now become the first combined tissue-engineering product recommended for approval across the EU. Prior to the regulation on advanced therapies and during the ATMP transitional period, MACI was available in the following European countries in accordance with national legislations: Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain and the United Kingdom.

Please also see EMA's complete press release "European Medicines Agency recommends approval of combined advanced-therapy product" for further information as well as the CHMP's summary of opinion.

Go back

GMP Conferences by Topics