-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.<\/p>\n
The twice-daily pill, Rhapsido, is approved for patients with symptoms of chronic spontaneous urticaria (CSU) despite standard therapies.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
Rhapsido showed safety profile that requires no lab monitoring, Novartis said.<\/p>\n
“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,\u201d said Lynda Mitchell, CEO of patient advocacy group Allergy & Asthma Network.<\/p>\n
Other treatments approved in the U.S. include Sanofi and Regeneron’s drug Dupixent and Novartis and Roche’s injectable treatment, Xolair.<\/p>\n
Novartis has completed regulatory submissions for Rhapsido in the European Union and Japan, and a priority review has been granted in China, it said.
\nThe drug is also being tested for a variety of immune-related conditions, including hidradenitis suppurativa and food allergies.<\/p>\n","protected":false},"excerpt":{"rendered":"
-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 […]<\/p>\n","protected":false},"author":2,"featured_media":2053,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[37],"tags":[599],"class_list":{"0":"post-2052","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-sitefansalaran-industry-news","8":"tag-novartis-skin-disease-drug-gets-us-approval"},"yoast_head":"\n