The European Commission has granted the unlimited extension of the EU-wide approval for the drug Spherox without additional conditions. In addition, Spherox will be removed from the list of drugs with additional surveillance measures, in which every drug of the class ATMP (Advanced Therapy Medicinal Products) will be included after approval.
With the grant, the European Commission follows the recommendation of the Committee for Human Medicinal Products (official abbreviation: CHMP) of the European Medicines Agency (EMA) made in February.
The Committee for Medicinal Products for Human Use is a scientific committee of the EMA that assesses the quality, effectiveness and safety of medicines for which pharmaceutical companies have applied for authorisation.
Tilmann Bur, CEO of CO.DON AG: "This important decision ensures the long-term use of our drug for the regenerative treatment of cartilage damage in the knee joint throughout the EU and is an essential basis for further business development and expansion in the markets addressed."
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 17.000 patients. CO.DON received EU-wide approval for this drug in July 2017, and approval for Switzerland in March 2019. 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: DE000A3E5C08). Board of Directors of the company: Tilmann Bur.
Source: Press release CO.DON AG from 05.05.2022