Theratechnologies to move forward with development of new single vial formulation for Egrifta
The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta (Tesamorelin for Injection).
Theratechnologies has announced that it will move forward with the development of the F4 single vial formulation instead of the 2 mg/vial presentation. The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta. Theratechnologies proposed that the development of the F4 single vial formulation be pursued in replacement of the current 2 mg/vial presentation, and the FDA allowed the company to proceed as such.
The F4 formulation has previously been used by Theratechnologies in a Phase II program. It will require a bioequivalence program before being submitted to the FDA for the currently approved indication for Egrifta. Presented in a single daily vial, the F4 formulation has the advantage of being four times more concentrated thus significantly reducing the volume of administration. It is also stable at room temperature which is a significant improvement as refrigeration by pharmacies and patients would no longer be required. This program will be initiated in the coming weeks.
"This is a positive development towards a single vial formulation. Bringing continued improvements remains an integral part of the lifecycle of our product," said Luc Tanguay, President an
d CEO, Theratechnologies Inc. "In addition to providing meaningful advantages for patients and pharmacies, this new formulation, if approved, will also eventually reduce our cost of goods," concluded Mr Tanguay.Related News
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