FDA approves efficacy supplement for Novartis's Rhapsido (remibrutinib)

The U.S. Food and Drug Administration approved a supplemental new drug application for Rhapsido on October 6, 2026, according to FDA drug approval records. The submission was classified as an efficacy supplement, numbered Submission 1 under application NDA218436, and its status was listed as approved.¹

Rhapsido is sponsored by Novartis. The product is formulated as an oral tablet containing the active ingredient remibrutinib at a strength of 25 milligrams.¹ The FDA assigned the submission a standard review priority rather than a priority review designation.¹

The agency's approval letter tied to this supplement is dated October 8, 2026, according to the application's documentation, which appears in the FDA's drugs database under the filename for the original application's first supplement. The underlying application record shows a submission status date of October 6, 2026, for this supplemental approval.¹

The FDA's public database entry does not specify the particular clinical indication or disease state covered by this efficacy supplement, nor does it detail what new data or label changes prompted the update. Readers seeking the specific clinical rationale should consult the full approval letter once it becomes available through the FDA's drug approval portal, as the agency's record only confirms the administrative status of the submission and the product's basic composition at this time.