Updated on 28 February 2013
Anika withdraws Hyalograft C after failing to address objections by EMA committees
Singapore: European Medicines Agency (EMA) has pointed out that Anika Therapeutics has withdrawn its application for centralized marketing authorization for the medicine Hyalograft C autograft (cultured autologous chondrocytes on hyaluronan based scaffold).
The drug 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 application for the marketing authorization for Hyalograft C autograft was submitted to the EMA on February 28, 2012. Hyalograft C autograft is an advanced therapy medicinal product (ATMP). At the time of the withdrawal, the medicine was under review by the EMA'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 (EU) 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 EMA, in order to obtain an EU-wide marketing authorisation.