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Positive Phase III Results Reported for Omalizumab (Xolair) in Treatment of Chronic Urticaria

Therapy controls itch, hives, and angioedema (October 5)

Based on results from the phase III ASTERIA I trial, omalizumab (Xolair, Novartis) appears to be safe and effective in the treatment of chronic spontaneous urticaria (CSU), a debilitating form of hives.

The new findings were presented Oct. 5 at the 22nd Congress of the European Association of Dermatology and Venereology (EADV) in Istanbul, Turkey.

Omalizumab is currently not approved for the treatment of CSU in the U.S.

The new data support the results from two previously reported pivotal phase III registration studies of omalizumab in CSU (ASTERIA II and GLACIAL), which were presented at medical congresses earlier this year. A regulatory application for omalizumab in CSU was filed with the FDA in the third quarter of 2013, based on data from nearly 1,000 patients included in these phase III studies.

The ASTERIA I trial showed that patients treated with omalizumab 300 mg responded as early as week 1 compared with week 4 in the placebo group (P < 0.0001). By week 12, all three omalizumab doses (75 mg, 150 mg, and 300 mg) were significantly superior to placebo in improving patients’ weekly Itch Severity Score (ISS) — the study’s primary endpoint. This effect was maintained throughout active treatment (week 24).

In addition, by week 12 more than half (52%) of the patients treated with omalizumab 300 mg had their CSU symptoms (i.e., itch and hives) well controlled, and 36% had no symptoms at all (P < 0.0001). At the same time point, patients treated with omalizumab 300 mg also experienced a significant increase in the proportion of days free of angioedema (P < 0.0001).

Omalizumab is a targeted therapy that binds to immunoglobulin E (IgE). The drug suppresses histamine-induced skin reactions, probably through its reduction of IgE and downstream effects on cellular-activation mechanisms.

Zolair (omalimumab) is currently approved only for the treatment of moderate to severe persistent allergic asthma.

Source: Novartis; October 5, 2013.

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