MONTREAL, May 01, 2018 — Theratechnologies Inc. (Theratechnologies) (TSX:TH) today announced that the Food and Drug Administration (FDA) has released Theratechnologies from post-approval commitments related to the approval of EGRIFTA®.
At the time of approval of EGRIFTA® on November 10, 2010, the FDA requested that the company conduct two large safety clinical trials.
The FDA determined that these two large-scale post-approval clinical trials are no longer required as the current labeling adequately reflects the safety profile of EGRIFTA®. The FDA also concluded that the size of the HIV patient population with lipodystrophy did not make such a requirement feasible.
In its most recent audited financial statements, for the year ended November 30, 2017, Theratechnologies estimated that the post-approval commitments would require an additional investment of US$13 million, which will no longer be required.
Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. Further information about Theratechnologies is available on the Company’s website at www.theratech.com and on SEDAR at www.sedar.com.