THTX - Upcoming FDA Decision: How likely is approval for EGRIFTA MDV?

2024-01-19 11:01:06 ET

Company:

Seeking Alpha Quant rating for THTX: Hold Wall Street Analysts’ Rating: Buy

Seeking FDA Approval for  EGRIFTA MDV, which is the F8 formulation of tesamorelin.

Type of Application: Supplemental Biologics License Application (sBLA)

FDA Decision (PDUFA) Date: January 22, 2024.

Drug’s Role: Tesamorelin reduces excess abdominal fat in HIV-infected adults with lipodystrophy by regulating growth hormone (“GH”) secretion.

Drug status: Currently, Tesamorelin is approved in the U.S. in its F4 formulation called EGRIFTA SV.  The F8 formulation is 2x more concentrated than F4, thereby enabling a smaller volume of administration, and delivery via a multiple-dose vial (“MDV”) that is reconstituted once a week vs. F4’s single-vial formulation.  If approved by the FDA, F8 formulation of tesamorelin will replace the current F4 formulation.

Competition: Tesamorelin is the only medication approved in the U.S. for the reduction of excess abdominal fat in HIV-positive adults with lipodystrophy. The new F8 formulation’s patent protection runs into 2033.

Revenues: EGRIFTA SV (Tesamorelin) generated ~$36.7 million in revenue for the first nine months of 2023, representing ~63% of total sales.

SA Analyst Opinion: Seeking Alpha's new analyst Sofia Raj explains why an FDA approval is likely for Tesamorelin F8 formulation.

“The original F1 formulation of tesamorelin was approved in 2010 and the current F4 in 2018. The sBLA for the new F8 is backed by pharmacokinetic studies showing its bioequivalence with F1. I don’t see much of a problem here with respect to approval, but I could be wrong, of course.”

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