FDA widens use of Novartis hives drug, easing pipeline concerns

The US Food and Drug Administration has expanded the use of Novartis (NVS) drug remibrutinib to treat adults with symptomatic dermographism, a chronic skin condition that causes recurring itchy welts, the Swiss drugmaker said.

The condition is a form of chronic hives in which scratching, rubbing or friction on the skin can trigger the welts.

The approval adds to momentum for remibrutinib, on which investors have increasingly focused after late-stage failures of the company’s cholesterol drug pelacarsen and its muscle-wasting disease therapy del-desiran heightened scrutiny of its pipeline.

Remibrutinib, branded as Rhapsido, is the first FDA-approved treatment specifically for adults with symptomatic dermographism whose symptoms are not adequately controlled by antihistamines, Novartis said. The decision extends the drug beyond chronic spontaneous urticaria, another common form of chronic hives, for which it is already approved in the US.

In the late-stage study, 29.3 per cent of patients taking remibrutinib achieved complete resolution of hives after 12 weeks, compared with 14 per cent of those receiving placebo. Patients began to show improvement as early as two weeks after starting treatment, the company said.

Novartis said the drug’s safety profile was consistent with earlier studies, with the most common side effects including nasal congestion, sore throat, headache, nausea and abdominal pain.

The approval follows positive late-stage trial results for remibrutinib in relapsing multiple sclerosis, a disease in which the immune system attacks the nervous system.