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Regulatory Update on Travere’s DUPLEX Study: Continuing on Accelerated Track

We know that many of you may have questions on the recent regulatory update from Travere Therapeutics on their sparsentan program for FSGS. We’re posting this to help you understand what it means:
  • Travere reported that despite the DUPLEX Study achieving its interim endpoint, the FDA indicated in recent interactions that the data from the DUPLEX Study are not yet adequate enough to support accelerated approval
  • Travere noted that FDA has acknowledged the high unmet need and the limited treatment options for people living with FSGS
  • For anyone participating in or following the DUPLEX Study, there are no changes to report at this time. The study will continue as planned to the final endpoint after 108 weeks of treatment
  • Travere is continuing to engage with regulators about generating additional data from DUPLEX in the first half of next year with the gold of submitting for accelerated approval in 2022
  • This means that sparsentan could potentially gain accelerated approval in the U.S. in 2023
  • Patient retention in the study is critical to providing the FDA with most robust data package possible to support a potential approval at the appropriate time
  • Travere remains confident in the potential for sparsentan to become a new treatment standard for FSGS, if approved
  • Travere also recently announced that their Phase 3 PROTECT Study in IgAN has completed enrollment and interim data from the trial are expected in August of this year
  • The interim data could also lead to an accelerated approval submission for IgAN

To read Travere Therapeutics’ original press release, click aquí.

Still want to learn more about how a drug gets approved by the FDA? Here is an FAQ list to help you find the information you’re seeking.

How does the FDA determine which study drugs are eligible for accelerated approval and which follow the normal regulatory timeline? 

The purpose of the FDA’s accelerated approval program is to get important new drugs to patients in need earlier. Generally speaking, the drug must have an impact on factors like survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more seriousone. The drug must fulfill an unmet medical need, which the FDA defines as providing a therapy where none exists or providing a therapy which may be potentially better than an available therapy.

How does this news impact my participation in the trial?

This news doesn’t change anything about your participation in this study. In fact, it’s very important that you remain in the study. Your continued participation is the only way Travere’s sparsenten will retain the potential to be granted accelerated approval. Please continue to do everything you are currently doing and comply with all study protocol/requirements. Be sure to talk to your study doctor if you have questions.

El FDA’s response to Travere’s request for accelerated approval was, ‘the available data from the interim assessment of the DUPLEX Study would not be adequate to support an accelerated approval at this time.’ Will they be able to submit for accelerated approval at a later time?

Although Travere was not granted accelerated approval at this time, they may still be able to submit for accelerated approval once additional data accrue in the DUPLEX Study. Subject to further discussions this summer, those data may become available to FDA in the first half of 2022.

What does this mean for Europe?

Travere continues to work through the conditional marketing authorization process and anticipates meeting with European regulators this summer to discuss next steps. Subject to their upcoming discussions with EMA, Travere is still planning for a submission in Europe this year. They expect to provide an update in the coming months.

 

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