Anika Therapeutics withdraws EU marketing application for Hyalograft C autograft

The European Medicines Agency says it has been formally notified by the European subsidiary of USA-based Anika Therapeutics (Nasdaq: ANIK) of its decision to withdraw the application for centralized marketing authorization for Hyalograft C autograft (cultured autologous chondrocytes on hyaluronan based scaffold). It was intended to be used for the surgical repair of symptomatic cartilage defects of the femoral condyle (medial, lateral) or trochlea, caused by acute or repetitive trauma in adults.

The MAA for Hyalograft C autograft was submitted to the Agency in February 2012. Hyalograft C autograft is an advanced therapy medicinal product (ATMP). At the time of the withdrawal, it was under review by the Agency's Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP). In its official letter, dated January 14, 2013, the company stated that it is withdrawing its application since, as part of the preliminary CAT/CHMP evaluation, major objections were identified, which the applicant was not able to address within the agreed timeframe.

Hyalograft C autograft has been used in a number of European Union countries since before the introduction of the EU regulation on advanced therapies in 2009. This regulation made it compulsory for advanced therapies already available in the EU to undergo evaluation by the Agency in order to obtain an EU-wide marketing authorisation.