Novartis’ fight to hold onto the chronic hives market is on track. With rivals closing in on its blockbuster Xolair, the Swiss drugmaker has reported positive top-line results from a pair of phase 3 clinical trials that will support filings for approval next year.
Currently, Novartis and Roche’s Xolair is the go-to therapy for patients with chronic spontaneous urticaria (CSU), the medical term for chronic hives, whose symptoms persist despite treatment with drugs such as antihistamines. But the market could change significantly in the coming months and years, with Sanofi and Regeneron’s Dupixent on track to win approval in the indication this year and Xolair biosimilars on the horizon.
Faced with the threats, Novartis has identified the oral BTK inhibitor remibrutinib as a molecule that can help it hold on to a sizable slice of the changing market. The top-line phase 3 data support Novartis’ belief in the candidate.
After 12 weeks of twice-daily oral dosing, participants in Novartis’ two phase 3 CSU trials experienced a significant change from baseline in their weekly urticaria activity score, a measure of hives and itching. The changes in people whose symptoms were inadequately controlled by H1-antihistamines caused the two trials to hit their primary endpoints. Novartis saw symptom improvements after two weeks.
“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,” Shreeram Aradhye, M.D., president, global drug development and chief medical officer at Novartis, said in a statement. “Remibrutinib … has the potential to be a first-in-class, oral treatment.”
The phase 3 trials add to evidence that remibrutinib may be free of liver toxicity issues that affect other BTK inhibitors. Novartis said the drug was “well-tolerated and demonstrated a favorable safety profile, including balanced liver function tests in active and placebo arms across both studies.” BTK inhibitors in development at Merck KGaA and Sanofi have been linked to liver injuries in other indications.
Novartis is yet to share any data from the phase 3 trials but, based on the top-line readout and midphase results, its candidate may provide similar efficacy to its biologic rivals in an oral dosage form. The Swiss drugmaker is now continuing the trials to their final 52-week readouts with a view to filing for approval next year.