Novartis receives FDA approval for oral CSU treatment Rhapsido

EAST HANOVER, N.J. - Novartis (Market cap: $243.5B), a pharmaceutical giant with impressive 76% gross margins and strong financial health according to InvestingPro, announced Tuesday that the U.S. Food and Drug Administration has approved Rhapsido (remibrutinib) as an oral treatment for adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine treatment.

Rhapsido is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU, a condition affecting approximately 1.7 million people in the United States. The medication is taken as a pill twice daily and requires no injections or laboratory monitoring. This approval comes as Novartis demonstrates strong market performance, with revenue growth of 13% over the last twelve months and a robust YTD return of nearly 17%.

According to the company’s press release, Rhapsido works by targeting BTK to inhibit the release of histamine and other proinflammatory mediators that cause the itchy hives characteristic of CSU.

The FDA approval is based on results from the Phase III REMIX-1 and REMIX-2 clinical trials involving patients who remained symptomatic on second-generation H1 antihistamines. The trials showed Rhapsido demonstrated superiority versus placebo in reducing itch, hives, and weekly urticaria activity at Week 12.

"CSU is a serious disease that can cause debilitating symptoms and unpredictable flares. It’s difficult to diagnose and manage," said Dr. Mark Lebwohl, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and member of the REMIX clinical trial steering committee.

The most common adverse events reported in the trials included nasopharyngitis, bleeding, headache, nausea, and abdominal pain.

CSU is characterized by recurring hives and itching for six weeks or more without an identified cause. More than half of CSU patients remain symptomatic despite increasing doses of antihistamines, the standard first-line treatment.

Novartis has completed regulatory submissions for Rhapsido across many countries, including the European Union, Japan, and China, with priority review granted in China.

The company is also investigating remibrutinib in clinical trials for other immune-related conditions, including chronic inducible urticaria, hidradenitis suppurativa, and food allergy. According to InvestingPro analysis, Novartis is currently trading below its Fair Value, suggesting potential upside opportunity. For detailed insights and comprehensive analysis of Novartis and other pharmaceutical companies, investors can access the Pro Research Report, available exclusively to InvestingPro subscribers.

In other recent news, Novartis reported robust financial results for the second quarter of 2025, with net sales increasing by 11% in constant currency and core operating income rising by 21%. The company also upgraded its full-year guidance, indicating expectations of continued growth despite challenges in the global pharmaceutical market. In addition to their financial performance, Novartis announced a new strategic collaboration with Argo Biopharmaceutical Co., Ltd., focusing on multiple cardiovascular assets in Argo’s pipeline. This agreement marks the third transaction between the two companies. Under the terms of the deal, Argo will receive an upfront payment of $160 million, with potential milestone and option payments reaching up to $5.2 billion, plus tiered royalties on commercial sales. Novartis has also shown a non-binding interest in participating in Argo’s next equity financing round. These developments highlight Novartis’s active role in expanding its partnerships and strengthening its financial outlook.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.