Calliditas Therapeutics said Tuesday that the FDA has extended its review of Nefecon, a targeted-release oral formulation of budesonide, by three months to December 15. The company is seeking an accelerated approval of the drug to treat patients with IgA nephropathy (IgAN), and was granted a priority review for the filing earlier this year.
The submission is based on data from Part A of the randomised Phase III NefIgArd trial designed to evaluate Nefecon versus placebo in about 200 adult patients with IgAN. Top-line data reported last November showed that the trial met its primary endpoint of proteinuria reduction compared to placebo, with results also demonstrating stabilisation of estimated glomerular filtration rate (eGFR) at nine months. The filing includes data from the mid-stage NEFIGAN study as well, which also met the same primary and secondary endpoints as NefIgArd.
According to Calliditas, the FDA requested further analyses of the NeflgArd trial data, which the company has provided and the agency has classified as a "major amendment" to the application. "The amendment mainly provides additional eGFR and other related analyses as further support of the proteinuria data provided in the…submission," Calliditas said.
CEO Renée Aguiar-Lucander noted that the company's filing for Nefecon "is the first time that the FDA is considering an approval on the basis of proteinuria as a surrogate endpoint for accelerated approval in IgAN, requiring an in-depth review process." Nefecon is also under review by the European Medicines Agency, which recently granted the drug an accelerated assessment procedure.
Travere Therapeutics, which is developing sparsentan as a potential therapy for IgAN, last month reported results from the Phase III PROTECT trial demonstrating a more than three-fold reduction of proteinuria after 36 weeks compared to irbesartan, the current standard treatment. Travere has said it expects to submit sparsentan for accelerated approval in the US in the first half of 2022 and also intends to file for conditional marketing authorisation in Europe (see ViewPoints: Travere's footsteps may be loud enough for Calliditas to hear). Sparsentan is a dual-acting antagonist of both endothelin type A and angiotensin II subtype 1 receptors.
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