Ferrer Internacional has decided to withdraw the marketing authorisation application (MAA) for Egrifta (tesamorelin) 2mg, powder for solution for injection in Europe.
Ferrer formally notified the European Medicines Agency of its decision.
The company submitted the MAA for Egrifta to the agency on 31 May 2011, during which it was under review by the agency's Committee for Medicinal Products for Human Use (CHMP).
As the CHMP considers that the provided data is insufficient to conclude on a positive benefit-risk balance, the company decided to withdraw the application
Egrifta was intended to be used for the treatment of excess visceral adipose tissue defined as a level greater than 130cm2 by imaging procedures, in treatment-experienced HIV-infected patients.
