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news.Ferrer Internacional has submitted a marketing authorization application (MAA) with the European Medicines Agency (EMA) for tesamorelin as a treatment for excess abdominal fat in adult HIV-infected patients with lipodystrophy.
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The MAA entitled, ‘TESAMORELIN FERRER,’ was filed on the basis of positive results from two Phase 3 clinical trials.
If approved, tesamorelin will receive marketing authorization for the 27 European Union member countries as well as for Iceland, Liechtenstein and Norway.
As per a licensing and distribution agreement between Ferrer and Theratechnologies, Ferrer holds European commercialization rights of tesamorelin and is responsible for conducting all related regulatory and commercialization activities.
Theratechnologies president and CEO John-Michel Huss said this European regulatory filing for tesamorelin constitutes an important step forward in meeting their corporate objective of maximizing the commercial potential of our flagship product in major markets.
"We were very pleased to obtain FDA approval for tesamorelin in the US and we are confident that our ability to help meet these patient needs, in partnership with Ferrer, will also be recognized in Europe," Huss said.