预约演示

J&J unwraps pivotal data on $6.5B autoimmune asset as it prepares to crash argenx and UCB's party

2024-07-01

临床3期临床结果上市批准

Johnson & Johnson plans to file for approval in generalized myasthenia gravis later this year and is pursuing other indications.

Johnson & Johnson has presented phase 3 data on generalized myasthenia gravisasthenia gravis (gMG), providing a look at how its $6.5 billion prospect matches up to the approved FcRn rivals from argenx and UCB.

Johnson & Johnsonbillion for nipocalimab and thenipocalimabmentgeneralized myasthenia gravis (gMG)ed up its first phase 3 win earlier this year. The top-line readout revealed thFcRnudy hit its pargenx endpUCBt but left key questions about J&J’s competitive positioning unanswered. J&J provided a closer look at the data at the European Academy of Neurology 2024 Congress Friday.

The study enrolled 153 antibonipocalimab gMG patients. PeMomenta Pharmaceuticals plus stanJ&Jd of care had a 4.7-point improvement on the MG-ADL symptom scale after 22 to 24 weeks of treatment. J&J saw a 3.25-point improvement in the contrJ&Jgroup. The drugmaker also linked nipocaJ&Jab to improvements on the QMG disease severity scale, scoring (PDF) a 4.86 reduction versus the 2.05 dip in the control arm.

UCB won (PDF) FDA approval on the strength of a study that linked Rysnipocalimab2.6-point improvement in MG-ADL compared to placebo at Day 43. Sixty-eight percent of Vyvgart patients in argenx’s pivotal trial had (PDF) at least a two-point improvement in MG-ADL versus 30% ofnipocalimabterparts on placebo.

UCB targeted a broader patient population than its rivals did. ArgRystiggoFDA approval for Vyvgart in 2021 in people who are positive for anti-AChR antibodies. UCB brVyvgartystiggo to market in 2023 with a label that covers patients with anti-AChR or anti-MuSK antibodies. J&J’s trial enrolled people with antibodies against AChR, MuSK and LRP4.

J&Jever, most gMG patients are eligible for treatment with the Argenxng drFDA. Up to 90% ofVyvgart with gMG have antibodies against AChR. The subpopulation of LUCB patientsRystiggod in the J&J trial accounts for up to 5% of cases.J&J AChR MuSK LRP4

J&J studied an intravenous dose of nipocalimab in the phase 3 trial. Vyvgart is given the same way. Argenx also has a subcutaneous pAChRct, Vyvgart Hytrulo, onLRP4 market. Rystiggo is a subcutaneous infusion. Argenx said its subcutaneous product drove growth in the first quarter, when global sales across both formulations rose to $398 million. J&J plans to file for approval in gMG later this year and is pursuing other indications.

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