Thursday, July 05, 2018
Theratechnologies Inc today announced that it has filed a supplemental new drug application (sNDA) with the Food and Drug Administration (FDA) for a single-vial formulation of EGRIFTA®.
The filing is based on bioequivalence studies which were completed earlier this year. The new single-vial formulation, known as “F4”, is four times more concentrated than the currently commercialized formulation of EGRIFTA®. The F4 significantly reduces the volume of administration and handling is more user-friendly as it comes in a single vial instead of two. Furthermore, the F4 is stable at room temperature which represents an advantage as EGRIFTA® now requires a cold-chain distribution network from the manufacture to the patient.
“Given its advantageous and convenient administration profile, the F4 could certainly be well received by patients and physicians. EGRIFTA® remains an important product for Theratechnologies and we are pleased by the perspective of making improvements to this unique and important treatment at this time in its lifecycle,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
The FDA generally takes about six months to review a sNDA. This means that a decision could be announced around our first quarter of 2019.