Health
FDA Accepts Biologics License Application for Sobi's NASP for Patients with Uncontrolled Gout
Sobi® (STO: SOBI), a global biopharmaceutical company dedicated to delivering innovative treatments for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) seeking approval for Nanoecapsulated Sirolimus plus Pegadricase (NASP), formerly SEL-212, for the treatment of uncontrolled gout. NASP is a novel, every 4-week infusion therapy consisting of nanoencapsulated sirolimus, which has a targeted immunomod
About this update from Swedish Orphan Biovitrum Ab
[{"type":"list","items":[{"val":[{"type":"text","content":"Submission includes results of the pivotal DISSOLVE I and II studies","length":68,"tagName":"p"}]},{"val":[{"type":"text","content":"NASP PDUFA date set for 27 June 2026","length":41,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":109,"olType":false},{"type":"text","content":"STOCKHOLM, Sept. 10, 2025 /PRNewswire/ -- Sobi® (STO: SOBI), a global biopharmaceutical company dedicated to delivering innovative treatments for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) seeking approval for Nanoecapsulated Sirolimus plus Pegadricase (NASP), formerly SEL-212, for the treatment of uncontrolled gout. NASP is a novel, every 4-week infusion therapy consisting of nanoencapsulated sirolimus, which has a targeted immunomodulating effect, and pegadricase, a pegylated uricase. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date of 27 June 2026.","length":697,"tagName":"p"},{"type":"text","content":"NASP potentially offers a significant advancement to this patient population for which there is a high unmet need and limited treatment options.","length":149,"tagName":"p"},{"type":"text","content":""There is a significant unmet need for patients living with uncontrolled gout," said Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs, and Chief Medical Officer at Sobi. "People living with uncontrolled gout experience chronic inflammation, often resulting in severe gout flares and a buildup of uric acid, leading to the formation of painful tophi. These clinical manifestations not only affect a patient's physical and mental quality of life but also their comorbid conditions. We believe NASP has the opportunity to provide a novel option for patients who are inadequately controlled with conventional treatment and look forward to working closely with the FDA to bring this important uricase-based therapy to patients as quickly as possible."","length":805,"tagName":"p"},{"type":"text","content":"The submission included results from the Phase 3 DISSOLVE I & II placebo controlled randomized clinical trials evaluating safety and efficacy of two different dose levels of NASP in adult patients with uncontr...