The FDA has approved a Novartis drug for chronic spontaneous urticaria (CSU), providing patients with an oral therapeutic alternative to currently injectable drugs. Regulatory decisions also make the new Novartis product the first drug for this rare skin disease.
In CSU, patients develop chronic urticaria or hives for six weeks or more. The cause of these beehives is not known, but it is believed to be due to imbalances in immune cells. The overactivity of proteins called tyrosine kinase (BTK) called Bruton plays a role in activating an immune cell called B cells. Novartis' Remibrutinib, brand Rhapsido, is a BTK inhibitor.
Rhapsido's regulator approved Tuesday to get the CSU approval of the two-daily BTK inhibitor. BTK inhibitors first attracted patients with cancer treatment. B cells drive certain hematologic cancers, so BTK inhibition provides a way to treat these malignant tumors. The role of B cells in inflammation opens the door to the potential application of BTK inhibitors in immune diseases.
Rhapsido was discovered and developed by Novartis. The FDA submission of the molecule is based on two placebo-controlled phase 3 studies that recruited CSU patients, despite the second-generation H1 antihistamines treating CSU patients. This 12-week study was statistically significant for statistically significant results for measures such as itching, urticaria and urticar activity. The most common adverse events include nasal congestion, sore throat, runny nose and bleeding.
According to Novartis, despite the dose increase of antihistamines, 1.7 million people in the U.S. live in CSU, and more than half of them still have symptoms. For patients whose CSU does not respond adequately to antihistamines, the next treatment option is Xolair, an injectable Roche antibody drug that blocks receptors involved in allergic and immune responses. Earlier this year, blockbusters sanofi and Regeneron Pharmaceuticals Dupixent expanded their tags to second-line treatments including CSU. The antibody drug is also administered by injection.
When Novartis announced the approval of Radatido, Dr. Giselle Mosnaim, a Ph.D., a professor at the University of Pritzker School of Medicine in Chicago, said Novartis drugs quickly relieved symptoms, providing Hives and Hives and itching control. Mosnaim, who is also an investigator in the clinical trial of Rhapsido, described the drug's approval as an important development in CSU care.
“This is important because it extends existing injection therapy and provides patients with an oral option that can be easily incorporated into their daily lives,” she said.
CSU is Dupixent's seventh FDA-approved immunologic instructions. Novartis has similar ambitions for Rhapsido, but as a verbal choice. The Swiss pharmacy giant is conducting clinical trials to evaluate the molecule as a treatment for chronically inducing urticaria, food allergies and the compound Hidradenitis. Meanwhile, regulatory submissions of CSU's Rhapsido are still under review in several markets, including the EU, Japan and China.
Photo: Sebastien Bozon/AFP via Getty Images
