Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.European Medicines Agency (EMA) has accepted marketing authorization application (MAA) of tesamorelin for review which was submitted by Theratechnologies partner Ferrer.
Subscribe to our email newsletter
The MAA, submitted under the name ‘TESAMORELIN FERRER,’ is based on the positive results from two Phase 3 clinical trials, which enrolled more than 800 patients, and follows a marketing approval by the US Food and Drug Administration received in November 2010.
Ferrer holds the rights to tesamorelin for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy in Europe and is responsible for conducting all related regulatory and commercialization activities, as per the distribution and licensing agreement between the two companies.
In the US tesamorelin is marketed under the trade name EGRIFTA.
EGRIFTA, a once-daily injection, is an analogue of the growth hormone-releasing factor (GRF).