-The U.S. Food and Drug Administration has approved Novartis’ oral treatment for patients with type of chronic inflammatory skin disease, the Swiss drugmaker said on Tuesday.
The twice-daily pill, Rhapsido, is approved for patients with symptoms of chronic spontaneous urticaria (CSU) despite standard therapies.
CSU is a long-term skin condition without a known cause, characterized by recurring hives – itchy, red welts – and sometimes swelling, lasting six weeks or more.
Rhapsido will cost $4,521 in the U.S. for 30 days and will be available to patients in the coming days, a company spokesperson told Reuters in an email.
The approval is based on results from two late-stage studies in which Rhapsido showed statistically significant improvements over placebo in itch severity, hive count and overall disease activity, Novartis said.
Patients achieved well-controlled disease as early as week 2, with about one-third experiencing complete relief from itches and hives by week 12, the company said.
The drug, chemically known as remibrutinib, works by inhibiting a protein called BTK, which plays a crucial role in triggering the body’s allergic response, and thus help prevent symptoms by calming overactive immune cells.
Rhapsido showed safety profile that requires no lab monitoring, Novartis said.
“This convenient new oral therapy offers a promising new way to manage CSU and potentially improve daily life for those living with this challenging condition,” said Lynda Mitchell, CEO of patient advocacy group Allergy & Asthma Network.
Other treatments approved in the U.S. include Sanofi and Regeneron’s drug Dupixent and Novartis and Roche’s injectable treatment, Xolair.
Novartis has completed regulatory submissions for Rhapsido in the European Union and Japan, and a priority review has been granted in China, it said.
The drug is also being tested for a variety of immune-related conditions, including hidradenitis suppurativa and food allergies.
