The European Medicines Agency has recommended the first marketing authorisation for an advanced therapy medicinal product.
The decision followed a positive opinion from the new 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.
The treatment 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, which was designed to ensure these treatments gain access to the EU market and to encourage competitiveness between pharma companies in the field.
The CAT assessed the scientific data provided to support the marketing authorisation application for ChondroCelect. On the basis of their positive opinion, the CHMP also recommended the therapy be granted marketing authorisation.
As part of the application, the company has been asked 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.