By Kate Goodwin

Pictured: Novartis Building/iStock, JHVE Photo
With Xolair’s patents set to expire over the next year, Novartis has been looking to strengthen its grip on the chronic spontaneous urticaria market. Thursday, the Swiss pharma shared positive Phase III results for chronic hives with its BTK inhibitor and announced plans to submit for regulatory approval next year.
In two late-stage studies, remibrutinib met the primary endpoint of change from baseline in a weekly urticaria activity score at week 12. While studies will continue for a full year, the BTK inhibitor demonstrated a rapid onset, improving patients’ symptoms in as little as two weeks.
Patients with chronic spontaneous urticaria (CSU) deal with chronic hives that can last for six weeks or longer. The trigger is internal, as opposed to allergen exposure. While antihistamines are the first line of treatment, around 60% of patients’ symptoms are inadequately controlled with antihistamines alone.
Oral drug remibrutinib, taken twice daily, successfully reduced the itchy hives and deep tissue swelling on the face, throat, hands and feet.
“CSU is a distressing and unpredictable disease, and patients urgently need effective, convenient and well-tolerated treatments that can provide rapid and sustained relief from the relentless itching and deep tissue swelling that greatly impact their daily lives,” Novartis CMO Shreeram Aradhye said in a statement.
Xolair, Novartis’ subcutaneous injection originally approved for asthma, has been one of the go-to treatments on the market for chronic hives since 2014. As the only injectable biologic indicated for the condition, it brought in $716 million in sales during the first half of 2023.
However, the patent for Xolair is set to expire this month and 2024 in the U.S. and Europe, respectively. Novartis appears to have found its replacement.
The company will present full data from the trials at an upcoming conference and submit it to global health regulating agencies beginning in 2024. The BTK inhibitor also shows potential across several immune-mediated conditions like hidradenitis suppurativa, Sjögren’s syndrome and food allergies, according to Novartis. Remibrutinib is also in a Phase III trial for multiple sclerosis, with a readout expected in 2026.
Novartis won’t be without competition in the urticaria market, though. Sanofi announced in March 2023 it was submitting a supplemental BLA for its Dupixent to treat patients aged 12 and up with CSU that isn’t controlled by antihistamines.
Sanofi’s subcutaneous injection is a monoclonal antibody currently approved for atopic dermatitis, asthma and other diseases with type 2 inflammation. The FDA has set a target action date of October 22, 2023.