Novartis Scores FDA Approval for Rhapsido in Chronic Hives, Intensifying BTK Inhibitor Competition

Novartis has secured FDA approval for Rhapsido (remibrutinib), an oral BTK inhibitor for the treatment of chronic spontaneous urticaria (CSU), commonly known as chronic hives. This approval marks a significant milestone in the pharmaceutical industry, potentially reshaping the landscape of immunology treatments and setting the stage for heightened competition in the BTK inhibitor market.

Rhapsido: A Novel Approach to Chronic Hives Treatment

Rhapsido represents a new mechanism of action in the treatment of CSU. As a BTK inhibitor, it targets the signaling pathway responsible for mast cell degranulation and the release of histamine, addressing both allergic and autoimmune components of the condition. The drug is positioned as a treatment option for adult patients with CSU who remain symptomatic despite H1 antihistamine treatment.

Dr. Mark Lebwohl from the Icahn School of Medicine at Mount Sinai, a member of the Remix clinical trial program's steering committee, highlighted Rhapsido's potential, stating, "It represents an exciting new option that has the potential to help a broad range of patients get fast relief."

The FDA's approval was based on the results of the phase 3 Remix-1 and Remix-2 trials. These studies demonstrated Rhapsido's superiority over placebo in reducing itch, hives, and weekly urticaria activity at Week 12. Long-term data presented last year showed that almost half of the patients were completely free of itch and hives at the one-year mark.

Market Implications and Competition

Novartis estimates that the target CSU population in the U.S. is approximately 400,000 out of 1.7 million people living with the disease. Currently, only about 20% of these target patients are being treated with existing options like Xolair or Dupixent, leaving significant room for Rhapsido's market penetration.

The approval of Rhapsido intensifies the competition in the immunology space, particularly in the realm of BTK inhibitors. This development comes just a month after Sanofi received FDA approval for its BTK inhibitor, Wayrilz, for immune thrombocytopenia (ITP). Sanofi has already initiated a phase 3 study of Wayrilz in chronic hives, setting the stage for a potential head-to-head competition with Rhapsido in the near future.

Victor Bulto, Novartis' U.S. president, emphasized the company's strategy to position Rhapsido as a treatment option immediately after antihistamines cease to be effective. This approach, coupled with Rhapsido's oral administration and safety profile that doesn't require lab monitoring, could give it a competitive edge in the market.

Future Prospects and Expansion

Novartis has ambitious plans for Rhapsido beyond CSU. The company is currently conducting trials in various other immunological conditions, including food allergies, chronic inducible urticaria, multiple sclerosis, hidradenitis suppurativa, and generalized myasthenia gravis. Positive results in these indications could significantly expand Rhapsido's market potential, with Novartis projecting multibillion-dollar peak sales.

As the pharmaceutical landscape continues to evolve, the approval of Rhapsido not only offers new hope for chronic hives patients but also signals an intensifying competition in the immunology sector, promising further innovations and treatment options in the years to come.