At the end of last week (see ad hoc announcement of May 21, 2021), CO.DON AG received the positive vote of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on the approval of the notification for the indication extension of the EU-wide approved human medicinal product for use with young people.
The CHMP assessment is the basis of the European Commission's decision on the EU-wide approval of the indication extension. In the past, the European Commission followed the recommendations of the CHMP in the vast majority of applications.
With the extended 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 a closed growth plate in addition to adult patients.
Tilman Bur, CEO of CO.DON AG: "According to our users, cartilage damage in young people occurs relatively frequently - be it through active activities in everyday life or sports or through degeneration of the knee cartilage at a relatively early age - we are pleased to present our therapy to now also be able to offer this age group throughout the EU.”
About CO.DON AG
CO.DON AG develops, produces and sells endogenous cell therapies for the minimally invasive repair of cartilage defects. The drug offered is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint using only the body's own cartilage cells. The method offered by CO.DON is currently used in over 200 clinics in Germany and has already been used in over 16.000 patients. In July 2017, CO.DON received EU-wide approval for this drug, and in March 2019 approval for Switzerland. At the Leipzig site, CO.DON built one of the largest plants for the production of human cells on an industrial scale for in-house and contract production. The shares of CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Board of Directors of the company: Tilmann Bur, Dr. Achim Simons.
For more information, please visit www.codon.de.
Source: Press release from CO.DON AG from May 25.05.2021th, XNUMX