Ferrer Internacional has formally notified the European Medicines Agency of its decision to withdraw the marketing authorisation application (MAA) for Egrifta (tesamorelin) 2mg powder for injection.
The company submitted the MAA for Egrifta to the agency on 31 May 2011, during which time it was under review by the agency's Committee for Medicinal Products for Human Use (CHMP).
The company had taken the decision to withdraw the application, as the CHMP considers the provided data to be insufficient to conclude on a positive benefit-risk balance.
According to 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.
According to the European Medicines Agency, the withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.
The GHRH analog tesamorelin (trade name Egrifta) drug was designed for the treatment of lipodystrophy in HIV patients under highly active antiretroviral therapy, and was approved by the US Food and Drug Administration in November 2010.