TiGenix NV (Euronext Brussels: TIG), the European leader in cell therapy, announced today that the Committee for Medicinal Products for Human Use (CHMP) has renewed for an additional five years its marketing authorisation for ChondroCelect in all of the 31 countries of the European Union (EU) and European Economic Area (EEA).
"ChondroCelect was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA) in October 2009, and it is the first ATMP to have its marketing authorisation renewed. The decision confirms the proven capability of TiGenix to develop and bring cell therapy products of real medical benefit to patients," said Maria Pascual, Vice-President of Clinical Operations and Regulatory Affairs at TiGenix. "After five years of post-commercialisation activity, and with an accumulated experience of over 1,000 patients, the CHMP confirms with its renewal that the benefit-risk balance remains positive for ChondroCelect."
Legislation of the European Union (EU) requires manufacturers of prescription medicines to apply for renewal of the marketing authorisation after a five year term and based on a re-evaluation of mainly safety data, only products that continue to have a positive risk-benefit ratio have their marketing authorisation renewed.
In parallel to its commercialisation efforts, TiGenix is conducting an open-label, multicentre, non-interventional study in patients treated with ChondroCelect for single symptomatic cartilage lesions of the knee of at least 2cm2 and symptom onset of less than 3 years. The results from an interim analysis of 153 patients in this study indicate statistically and clinically significant improvement in all KOOS subscale scores versus baseline. These data from treatment in daily clinical practice confirm the positive results from previous randomised clinical trials.