Novartis Remibrutinib Receives Positive European Opinion, Meets Endpoint in CIndU Trial
Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization for remibrutinib, an oral treatment for chronic spontaneous urticaria in adult patients. The recommendation covers use of remibrutinib for adults with chronic spontaneous urticaria who have inadequate response to H1-antihistamine treatment.
Separately, Novartis announced positive results from the Phase 3 trial of remibrutinib in chronic inducible urticaria. In the phase 3 trial, dubbed RemIND, remibrutinib achieved significantly higher complete response rates than placebo at Week 12, the primary endpoint for the study. This key goal was met for the three most prevalent types of chronic inducible urticaria, namely symptomatic dermographism, cold urticaria and cholinergic urticaria.
The drug is classified as a Bruton's tyrosine kinase inhibitor. Remibrutinib is a selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives and swelling. By reducing histamine release, remibrutinib helps relieve the symptoms of chronic inducible urticaria.
The positive European opinion is based on results from the REMIX-1 and REMIX-2 Phase III trials. According to the company, remibrutinib demonstrated improvements in itch and hives symptoms beginning at Week 1, with benefits maintained through Week 52. The trials also showed improvements in quality of life and sleep measures early in treatment.
Safety data from both studies indicated remibrutinib was well tolerated through Week 52, with no liver safety concerns reported, according to Novartis.
Chronic spontaneous urticaria is characterized by recurring hives and itching episodes that can persist for six weeks or longer without an identifiable cause. Chronic inducible urticaria is a form of chronic urticaria characterised by hives or swelling, with external triggers, like pressure, sunlight, friction, heat, cold or water. It is a chronic skin condition affecting an estimated 0.5 percent of the population, or 29 million people worldwide.
Following the committee recommendation, the European Commission is expected to issue a final decision within approximately two months. The full dataset from the RemIND trial will be submitted to health authorities worldwide in the coming months, and the RemIND trial findings will be presented at upcoming medical congresses.
In the US and China, remibrutinib is approved for the treatment of adult patients with chronic spontaneous urticaria who have an inadequate response to H1-antihistamines, under the brand name Rhapsido. Novartis has submitted a supplemental New Drug Application to the FDA seeking approval of remibrutinib for the treatment of symptomatic dermographism, the most prevalent type of chronic inducible urticaria.