Amgen secures Phase 3 successes in atopic dermatitis and myasthenia gravis

Amgen has announced promising outcomes from crucial trials involving two of its drugs, providing a significant boost to the company's immunology efforts. The experimental drug rocatinlimab and the already approved Uplizna both showed positive results in their respective Phase 3 tests.

Rocatinlimab, an anti-OX40 monoclonal antibody, demonstrated success in treating atopic dermatitis. In the ROCKET-Horizon trial, the drug achieved its primary endpoint and all secondary endpoints with statistical significance. Specifically, 32.8% of patients experienced a 75% reduction in the Eczema Area and Severity Index (EASI-75) after 24 weeks, compared to 13.7% of patients on a placebo.

This success places Amgen ahead of Sanofi, which is developing amlitelimab, targeting a related pathway. While Sanofi's first Phase 3 results for amlitelimab aren't expected until late 2026, Amgen is already conducting eight Phase 3 trials for rocatinlimab. By next July, Amgen expects results from at least four more trials, exploring different doses and uses, including combination and maintenance therapies, as well as a trial in adolescents. This early progress may allow Amgen to file for FDA approval sooner, giving it a competitive edge in the market.

Rocatinlimab was licensed from Kyowa Kirin in 2021, shortly after Phase 2 results were reported. Amgen paid $400 million upfront and committed up to $850 million in milestone payments. In contrast, Sanofi acquired amlitelimab through a $1.1 billion buyout of Kymab in 2021, and despite the delays, Sanofi remains optimistic about its potential.

In addition to the rocatinlimab news, Amgen's drug Uplizna also reached its primary endpoint in a Phase 3 trial for myasthenia gravis, an autoimmune disease. Uplizna showed a significant improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale. After 26 weeks, patients on two doses of Uplizna improved by -4.2 points, compared to -1.9 points for those on placebo (p<0.0001). Four out of five secondary endpoints were also met with statistical significance.

Uplizna’s recent success builds on its earlier achievements. The drug recorded a successful Phase 3 study in IgG4-related disease in June and was initially approved in 2020 for treating neuromyelitis optica spectrum disorder (NMOSD), another autoimmune condition affecting the eyes.

These trial results underscore Amgen's strengthening position in the immunology sector. The firm’s strategic acquisitions and licensing agreements are bearing fruit, allowing it to advance its drug pipeline effectively. As the company awaits further data from ongoing trials, its early successes with rocatinlimab and Uplizna position it well for future growth and competitive advantage in the immunology market.