EU CHMP recommends authorisation for Spherox from CO.DON AG., to treat adult patients who have symptomatic articular cartilage defects.

The CHMP of the European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for a new advanced therapy medicinal product (ATMP) caled Spherox from CO.DON AG., to treat adult patients who have symptomatic articular cartilage defects in the femoral condyle (the ball-shaped end of the thigh bone in the knee) and the patella (knee cap), where the size of the affected area is no larger than 10 cm�.

Damage to the articular cartilage of the knee is a common orthopaedic problem which often occurs in young, active people. It can result from direct trauma, repetitive injuries, fractures, or degenerative and inflammatory conditions. People with this type of damage experience recurrent pain and swelling of the joint, locking of the knee and may be impaired in their ability to walk or participate in sports. To restore functionality of their knee, patients often opt for surgery which aims to fill the cartilage loss.

Spherox is an ATMP composed of spheroids, i.e. spherical aggregates of chondrocytes (cells that are found in healthy cartilage). In this therapy, a small piece of cartilage is excised from the healthy cartilage and chrondrocyte spheroids are produced in a laboratory. These spheroids are then inserted arthroscopically in the patient knee where they form new tissue to heal the defect..

Spherox was assessed by the Committee for Advanced Therapies (CAT), EMA�s specialised scientific committee for ATMPs, such as gene or cell therapies. At its May 2017 meeting, the CAT recommended a positive opinion for Spherox to the Committee for Medicinal Products for Human Use (CHMP). The CHMP agreed with the CAT�s recommendation and adopted a positive opinion for the authorisation of Spherox across the EU at its 15-18 May 2017 meeting.