Novartis’ RemIND trial of oral remibrutinib meets main endpoint
Novartis has reported that its pivotal part III trial RemIND, evaluating oral remibrutinib in continual inducible urticaria (CIndU), has met its main endpoint.
The examine met this endpoint for the three commonest CIndU varieties: chilly urticaria, cholinergic urticaria and symptomatic dermographism, with noticeably larger full response charges in comparison with placebo at week 12.
Uncover B2B advertising that delivers
Mix enterprise intelligence and editorial excellence to achieve engaged professionals throughout 36 main media platforms.
Extra info
The randomized, international, multicenter, placebo-controlled, double-blind, parallel-group part III examine assesses the protection, tolerability and efficacy of remibrutinib in adults with CIndU who haven’t responded adequately to H1 antihistamines.
The primary final result measured was the share of full responders at week 12, evaluated through problem testing for every of the three CIndU subtypes.
Novartis has filed a supplemental new drug software (sNDA) with the U.S. Meals and Drug Administration (FDA) for remibrutinib in symptomatic dermographism.
The corporate plans to submit the total information set to international well being authorities within the coming months and current RemIND’s findings at upcoming medical conferences.
Angelika Jahreis, head of immunology growth at Novartis, mentioned: “The optimistic outcomes from the RemIND examine in three several types of CIndU underline the potential of oral remibrutinib to attain full symptom reduction for folks with CIndU and construct on the latest FDA approval for continual spontaneous urticaria (CSU).
“Immediately’s findings reinforce that remibrutinib could possibly be the primary focused remedy to enhance spontaneous and inducible types of continual urticaria, addressing a significant hole in look after folks with these circumstances.”
Remibrutinib is a extremely selective Bruton tyrosine kinase (BTK) inhibitor that blocks the pathway liable for histamine launch.
By limiting the discharge of histamine, it helps cut back signs akin to hives and swelling related to CIndU. In China and the US, remibrutinib obtained approval for grownup CSU sufferers refractory to H1 antihistamines.
The remedy is being additional investigated for different immune-mediated circumstances, together with meals allergy and hidradenitis suppurativa, in addition to neuroscientific indications.
Earlier this week, Novartis introduced last information from the Section III ALIGN trial, highlighting that Vanrafia (atrasentan) slowed the decline of kidney operate in adults with immunoglobulin A nephropathy (IgAN).
