Johnson & Johnson Halts Nirogacestat Trial for Rheumatoid Arthritis

Generated by AI AgentMarket Intel
Friday, Aug 29, 2025 10:10 am ET1min read
Aime RobotAime Summary

- Johnson & Johnson halts nirogacestat RA trial after Phase 2a study showed no significant clinical benefit when combined with anti-TNFα therapies.

- The 12-week trial confirmed safety but failed to demonstrate efficacy improvements over anti-TNFα monotherapy in rheumatoid arthritis patients.

- Nirogacestat, projected to generate $5B+ annual sales, highlights risks in autoimmune drug development amid competitive market pressures.

- Humira's $21B 2021 sales face biosimilar competition since 2023, underscoring pharmaceutical industry challenges in maintaining blockbuster dominance.

Johnson & Johnson has announced the termination of its experimental antibody drug, nirogacestat, in combination with anti-tumor necrosis factor alpha (anti-TNFα) therapies for the treatment of rheumatoid arthritis (RA). This decision follows the results of the 2a phase DAISY concept verification study, which assessed the combined use of nirogacestat with AbbVie's blockbuster drug Humira and other anti-TNFα therapies.

The 12-week trial data indicated that while no new safety issues were identified, the combination of nirogacestat and anti-TNFα therapies did not demonstrate significant clinical benefits over the use of anti-TNFα therapies alone in RA patients.

stated, "Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of this combination therapy for RA treatment."

Nirogacestat was a pivotal development project for Johnson & Johnson in the field of rheumatology, with the company previously predicting its peak annual sales to exceed $5 billion. This setback highlights the high risks associated with the development of innovative drugs, particularly in the competitive field of autoimmune disease treatment.

Humira, a global best-selling drug, generated nearly $21 billion in sales in 2021. However, starting from 2023, it has faced sales pressure due to the introduction of biosimilar drugs by companies such as

. This development underscores the challenges faced by pharmaceutical companies in maintaining market dominance in the face of increasing competition from biosimilar drugs.

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