The Therapeutic Products Directorate of Health Canada has accepted to review Theratechnologies' Egrifta (tesamorelin for injection) new drug submission (NDS).
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Egrifta, 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).
Egrifta or tesamorelin is intended for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
The NDS for Egrifta is supported by the positive results of two Phase 3 trials which evaluated around 800 patients.
Theratechnologies president and CEO John-Michel said they look forward to working with Health Canada throughout the review process.
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