FDA approves Xolair for chronic idiopathic urticaria

The Food and Drug Administration has approved Xolair (omalizumab, Novartis) for the treatment of chronic idiopathic urticaria in patients ages 12 and older.

Omalizumab’s new use is for patients with chronic idiopathic urticaria (CIU) - a form of chronic hives - who remain symptomatic despite treatment with H₁-antihistamines, according to a news release. Patients with CIU get hives that occur spontaneously, without an identifiable cause, and the hives can recur for up to six weeks or longer.

Up to 50 percent of patients with CIU suffer from the hives despite H₁-antihistamine treatments, which previously was the only FDA-approved therapy for the condition. As many as 1.5 million people in the United States suffer from CIU.

Xolair’s clinical profile for the treatment of CIU was tested in two clinical studies - ASTERIA 1 and ASTERIA 2. The studies evaluated 641 patients ages 12 to 75, who received subcutaneous injections of Xolair at doses of 75 mg, 150 mg, 300 mg, or placebo. The drug or placebo was administered every four weeks for 24 weeks for ASTERIA 1, and for 12 weeks with ASTERIA 2. Patients in the studies continued to receive their H₁-antihistamine treatments.

Patients who remained symptomatic with the antihistamine treatment were studied for efficacy of Xolair in two phase-3 studies. The studies involved the Itch Severity Score (ISS) and the weekly hive count score, with potential scores ranging from 0 to 21 for both scales.

In the first study, the 150 mg dosage of Xolair improved ISS by a reduction of 6.7 (47 percent), while the 300 mg dosage improved ISS by a reduction of 9.4 (66 percent) at week 12, compared to a reduction of 3.6 (25 percent) for patients given placebo. A larger proportion of patients (36 percent) treated with Xolair 300 mg reported no itch and no hives at week 12, compared to patients treated with Xolair 150 mg (15 percent), and patients in the placebo group (9 percent). Similar results were seen in the ASTERIA 2 study. The 75 mg dose didn’t demonstrate consistent evidence of efficacy and was not approved for use.

“For CIU patients, it can take months or even years to get the right diagnosis and some relief,” Novartis Pharmaceuticals President André Wyss said in the news release. “Novartis is proud to have collaborated with clinicians to bring forward a new treatment option for those who suffer from this serious skin condition.”