FDA grants fast track designation to brepocitinib for noninfectious uveitis
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The FDA granted fast track designation to brepocitinib for the treatment of nonanterior noninfectious uveitis, according to a press release from Priovant Therapeutics.
“This fast track designation will help brepocitinib potentially address the unmet need in non-infectious uveitis (NIU), a severe ocular autoimmune disease with limited treated options. NIU is the fourth leading cause of blindness among the working age population in the developed world,” Ben Zimmer, CEO of Priovant, told Healio.
In addition, 24-week widefield fluorescein angiography results from the phase 2 NEPTUNE study were presented at the Euretina congress. Regarding the primary efficacy endpoint of treatment failure at 6 months, a 45 mg dose of the tyrosine kinase 2 and Janus kinase 1 inhibitor, a once-daily oral therapy, showed the “numerically greatest efficacy benefit observed to date of any therapy evaluated” for noninfectious uveitis. Brepocitinib 45 mg demonstrated a mean 4.4-point decrease in retinal vascular leakage vs. a mean 0.5-point decrease for brepocitinib 15 mg, the release said.
Priovant also announced that it has dosed the first patients in the global multicenter phase 3 CLARITY study, which will compare brepocitinib 45 mg and placebo in 300 participants with nonanterior noninfectious uveitis. The primary endpoint will be time to treatment failure.
“The magnitude and consistency of dose-dependent benefit across multiple independent measurements of inflammation, visual acuity and macular edema give us high confidence heading into phase 3,” Zimmer said.
Priovant plans to release 52-week data from NEPTUNE by the end of the year.
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