Teltow / Leipzig, 25 May 2021 - CO.DON AG received at the end of last week (see adhoc announcement of 21 May 2021) the positive vote of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). on the approval of the application for indication extension of the EU-approved medicinal product for human use for use in adolescents.
The CHMP's assessment is the basis for the European Commission's decision on the EU-wide authorisation of the indication extension. In the past, the European Commission followed the recommendations of the CHMP in the vast majority of applications.
With the expanded indication for the EU, the treatment of symptomatic articular cartilage defects of ICRS Grade III or IV of the femoral condyle and the patella of the knee with defect sizes of up to 10 cm² is now also possible in adolescents with closed growth plates in addition to adult patients.
Tilman Bur, CEO of CO.DON AG: "According to our users, cartilage damage in adolescents occurs relatively frequently - be it due to activities in everyday life or sports or also due to degeneration of the knee cartilage at a relatively early age - we are pleased to now be able to offer our therapy for this age group throughout the EU."
CO.DON AG develops, produces and distributes autologous cell therapies for the minimally invasive repair of cartilage defects. The product being marketed is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint that uses only the patient's own cartilage cells ("autologous chondrocytes"). CO.DON's method is currently used in over 200 clinics in Germany and more than 16,000 patients have already been treated. In July 2017 CO.DON AG received central EU marketing authorisation for this product, followed by the marketing authorization for Switzerland in March 2019. At the Leipzig site, CO.DON has built one of the largest facilities for the production of human cells on an industrial scale for in-house and contract manufacturing. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Tilmann Bur, Dr Achim Simons.
Further information is available from www.codon.de.
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