Priovant: FDA aceita o NDA do brepocitinib para dermatomiosite, com Priority Review

FDA has accepted the NDA for brepocitinib in dermatomyositis and granted Priority Review. The agency set a PDUFA target action date in Q3 2026, with launch expected end of September 2026. The filing is supported by the positive Phase 3 VALOR trial, the first 52-week placebo-controlled study in dermatomyositis.

Fatos principais

Arquivado: 3 de mar. de 2026, 12:13
Evento: Pedido aceito
Direção: Positivo
Empresa: ROIVRoivant
Ativo: brepocitinib
Fonte: SEC 8-K
Confiança: Com fonte
Calendário: Decisão da FDA (PDUFA) · 1 de jul. de 2026 · Aprovado

Trecho da fonte

EX-99.1 2 ef20066998_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis • FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026 • Priority Review supported by positive Phase 3 VALOR results, the first positive 52-week placebo-controlled trial in dermatomyositis • If approved, brepocitinib would represent the first targeted therapy approved for dermatomyositis DURHAM, NC, March 03 , 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for brepocitinib for the treatment of dermatomyositis (DM) and has granted the application Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026. The company expects to launch the drug in the United States at the end of September 2026. The FDA grants Priority Review to applications for medicines that, if approved, provide significant improvements in the safety or effectiveness of the treatment of a serious condition. The Priority Review designation was supported by the significant unmet medical need in dermatomyositis and the results from the Phase 3 VALOR study evaluating brepocitinib in DM. VALOR (N=241) was the longest and largest interventional dermatomyositis trial to date

SEC 8-K