Travere takes a hit as FDA staffers shoo off their accelerated drug pitch
Three months after the execs at Travere Therapeutics $TVTX picked up interim data for its treatment for a rare kidney disease and made a beeline for the FDA in search of an accelerated approval, they’re being turned around and pointed back to the clinic.
According to the biotech — more famously known for being founded as Retrophin by ex-CEO Martin Shkreli, now doing prison time for fraud — regulators at the FDA told them that “the available data from the interim assessment of the DUPLEX Study (of sparsentan) would not be adequate to support an accelerated approval at this time.”
Shares slid 12% on the news Wednesday morning of this latest twist in the regulatory trail.
The door may be closed right now, but it’s not locked. Travere added that they might be persuaded to push ahead on an accelerated approval with “sufficient additional estimated glomerular filtration (eGFR) data from the DUPLEX Study in the first half of 2022.”
CEO Eric Dube promised an update on the filing in Q3, holding out a shot at an OK in 2022.
As Nicole DeFeudis reported, their Phase III DUPLEX study assigned patients to receive either sparsentan or Avapro, the current standard of care. At 36 weeks, 42% of patients in the treatment arm achieved the FSGS partial remission of proteinuria endpoint, versus 26% in the Avapro group, according to Travere. The confirmatory primary endpoint, which is the rate of change in estimated glomerular filtration rate over 108 weeks, is still in play.