PITTSBURGH , Jan. 10, 2024 /PRNewswire/ -- PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce that it was selected by UCB to dispense ZILBRYSQ®, a new FDA-approved therapy for the treatment of adults with gMG who are anti-AChR antibody positive. 1
ZILBRYSQ® (zilucoplan) Is Now Commercially Available in the U.S
ATLANTA, Oct. 17, 2023 /PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that ZILBRYSQ® (zilucoplan) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.1
UCB announces U.S. FDA acceptance of new drug application and EMA MAA validation for zilucoplan for the treatment of generalized myasthenia gravis in adult patients
UCB is teeing up a slate of new regulatory filings after spelling out Phase III successes for a pair of experimental drugs being tested for myasthenia gravis, including one that it paid more than $2 billion to get ahold of. But their cut of the pivotal data raises some big red flags for how they might contend with the leaders in the field at AstraZeneca’s Alexion subsidiary.
UCB has announced that zilucoplan, its developmental treatment for adults with generalized myasthenia gravis (gMG) has been granted Promising Innovative Medicine (PIM) designation in the UK by the MHRA. This marks the first investigational treatment with a published PIM designation for gMG in the UK.
BRUSSELS and ATLANTA, Feb. 4, 2022 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced positive topline results from the RAISE (NCT04115293) triali evaluating its investigational treatment zilucoplan, a self-administered, subcutaneous (SC) peptide inhibitor of complement component 5 (C5 inhibitor), versus placebo in adults with generalized myasthenia gravis (gMG).
Ra Pharmaceuticals, Inc. (Nasdaq:RARX) today announced that full results from its Phase 2 clinical trial of zilucoplan in patients with generalized myasthenia gravis (gMG) were published online in JAMA Neurology. The JAMA Neurology publication can be accessed here.
Will enhance UCB’s leadership potential in myasthenia gravis by adding zilucoplan, a peptide inhibitor of complement component 5 (C5) currently in phase 3, to the UCB pipeline alongside to UCB’s rozanolixizumab, an FcRn targeting antibody also in phase 3