Novartis AG (NVS,NOVN.SW), a healthcare firm, on Wednesday announced positive results from the Phase 3 trial of its oral drug, Remibrutinib, in chronic inducible urticaria.
In the phase 3 trial, dubbed RemIND, Remibrutinib achieved significantly higher complete response rates than placebo at Week 12, i.e., the primary endpoint for the study. This key goal was met for the three most prevalent types of chronic inducible urticaria (CIndU), namely symptomatic dermographism, cold urticaria and cholinergic urticaria.
Novartis said that the full dataset will be submitted to health authorities worldwide in the coming months, and the RemIND trial findings will be presented at upcoming medical congresses.
CIndU 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, noted Novartis.
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 CIndU.
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 (sNDA) to the FDA seeking approval of remibrutinib for the treatment of symptomatic dermographism, the most prevalent type of CIndU.
NVS has traded between $97.72 and $167.29 in the last one year. The stock closed Tuesday's trade at $166.17, up 1.88%.
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