News release...Health Canada Accepts to Review Theratechnologies' New Drug Submission for EGRIFTA(R)
Last Update: 8/16/2011 8:31:56 AM
MONTREAL, CANADA, Aug 16, 2011 (MARKETWIRE via COMTEX) -- Theratechnologies Inc. (TH)(THER) today announced that the Therapeutic Products Directorate of Health Canada has accepted to review its New Drug Submission (NDS) for EGRIFTA(R) (tesamorelin for injection) filed in late June.
"We are pleased that Health Canada has completed the screening of our NDS for EGRIFTA(R) and has accepted to move forward with the technical review," stated Mr. John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies. "We look forward to working with Health Canada throughout the review process," added Mr. Huss.
EGRIFTA(R), or tesamorelin, is an analogue of the growth hormone-releasing factor (GRF) proposed for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. Currently, there is no approved treatment for lipodystrophy in HIV patients available in Canada.
The NDS is based on the positive results from two Phase 3 clinical trials, which enrolled more than 800 patients, and follows a marketing approval for EGRIFTA(R) by the U.S. Food and Drug Administration received in November 2010. Additional applications for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy are currently under review with regulatory agencies in Europe and Israel.
About EGRIFTA(R)
EGRIFTA(R), a once-daily injection, is a novel, stabilized analogue of GRF. GRF is a hypothalamic peptide that acts on the pituitary cells in the brain to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH). GH has been shown to play an important role in regulating lipid metabolism and body composition (e.g., increasing muscle mass and reducing fat) (1). For more information about EGRIFTA(R), including its U.S. Food and Drug Administration approved indications, limitations of use and complete risk profile, please consult the full U.S. Prescribing Information available at www.egrifta.com/Pdfs/Prescribing_Information.pdf . EGRIFTA(R) has not been approved in Canada.