MONTREAL, CANADA--(Marketwired - Nov 1, 2013) - Theratechnologies Inc. (TH.TO) today announced that Health Canada has agreed to resume review of the tesamorelin New Drug Submission (NDS) and has rescinded the notice of non-compliance/withdrawal (NON/w) it issued in March 2013.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 August 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 NON/w 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.
Theratechnologies (TH.TO) is a biopharmaceutical company that specializes in innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor peptides. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on the SEC's website at www.sec.gov.