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Despite positive trial, Roche says Enspryng fell short of expectations in myasthenia gravis
2024-03-21
临床3期临床结果上市批准
Roche and Chugai's Enspryng won an original FDA approval in 2020 in neuromyelitis optica spectrum disorder.
RochedevelChugaioftEnspryngo spot tidbits of positive information frneuromyelitis optica spectrum disorderis doing the opposite for its Enspryng study in the competitive autoimmune disorder of generalized myasthenia gravis (gMG).
Enspryng delivered a statistically significant benefit in improving symptoms and daily life metrics Rocheused on top of standard-of-care therapy in gMG patiencompetitive autoimmune disorderve, generalized myasthenia gravis the disease population. The phase 3 LUMINESCE trial has met its primary endpoint as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at 24 weeks.
Enspryng in announcing the positive readout, Roche’s Chugai said the degree of clinical benefit observed “did not reach our expectations.”AChRMyasthenia Gravis
Just a few days ago, Roche touted Enspryng’s Roche-in-disease potential in MG” during a neurology investor event, a company presentation shows. At that time, Roche highlighted the remaining unmet need in gMG, including about 10% to 30% of patients who fail on standard-of-care therapies, and at least 60% of patients on novel biologics who couldn’t achieve stable remission.
Roche’s labeling of tRochespryng’s data as weak was a relief for other developers of biologics for gMG, such as Johnson & Johnson, UCB and argenx. As EnspryngRochetested under the skin once every four weeks in LUMINESCE, it could have held a convenience edge over other once-weekly regimens given either subcutaneously or through intravenous infusions.
Roche Enspryng inhibits IL-6 signaling, UCB’s Rystiggo and argenx’s Vyvgart are anti-FcRn antibodies. And J&J juJohnson & JohnsonitUCB outcome for theEnspryngRn candidate nipocalimabin a phase 3 gMG trial, although the magnitude of improvement remains under wraps. AstraZeneca’s Soliris and long-acting Ultomiris are C5 inhibitors.
OriginEnspryngroved by tIL-6DA in late 2UCB as the first FcRn inhibiVyvgartvgartanti-FcRn antibodies $1.2 J&Jlion in sales from gMG. Enspryng, with a 2020 FFcRnod in certain patients with the neurological autoimmune disease of neuromyelitis optica spectrum disorderAstraZenecaratSolirisSwiss francs ($28Ultomiris) in C5 inhibitorsC523 sales.
Despite the disappointing gFDAresults, Roche remains commFcRn inhibitorFcRnd to developVyvgartpryng in other neurological autoimmune and inflammatoEnspryngses. Phase 3 tFDAls are ongoing for Enspryng in myeneurological autoimmune diseasen-asneuromyelitis optica spectrum disorderhalitis, as well as thyroid eye disease.
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