Mr. Denis Boucher reports
THERATECHNOLOGIES INC.: HEALTH CANADA AGREES TO RECONSIDER TESAMORELIN
Health Canada has agreed to resume review of Theratechnologies Inc.'s tesamorelin new drug submission (NDS) and has rescinded the notice of non-compliance/withdrawal it issued in March, 2013.
This decision is based on recommendations contained in a report issued by a reconsideration panel. It was responsible to hear arguments from Theratechnologies and Health Canada on Aug. 23, 2013, and to submit recommendations to the Office of Science of Health Canada. The reconsideration panel was of the opinion that the review of the tesamorelin NDS should be reinstated. This recommendation was supported by the Office of Science, and, ultimately, by the Health Products and Food Branch of Health Canada.
As a result, the NDS for tesamorelin will be reinstated, and the review of the file will resume at the stage it was at the time the notice of non-compliance/withdrawal was issued.
The NDS for EGRIFTA was originally submitted to Health Canada in June, 2011. It was based on results from two phase 3 clinical trials, which enrolled more than 800 patients and followed marketing approval by the Food and Drug Administration in the United States in November, 2010.
Currently, there are no approved treatments for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy available in Canada.
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