New data from a late-stage study of Novartis/Genentech's omalizumab add further evidence to show that the drug is safe and effective as a treatment for a debilitating form of hives.
The Swiss drug giant has now presented data from the final of three Phase III studies on the drug, which is already on the market for asthma as Xolair, assessing its use to treat chronic spontaneous urticaria, a chronic form of hives with limited approved treatment options.
The ASTERIA I study showed that patients on omalizumab 300mg responded as early as week 1 compared to week 4 in the placebo group, and, by week 12, all three doses of the drug (300mg, 150mg and 75mg) were "significantly superior to placebo" in improving patients' weekly Itch Severity Score (ISS), the primary endpoint of the study, with this benefit maintained throughout active treatment (week 24).
Crucially, findings also showed omalizumab 300mg-treated patients experienced nearly twice the improvement in their quality of life compared to those taking placebo by week 12, by which more than half (52%) of this dose grope had their CSU symptoms (itch, hives) well controlled and 36% had no symptoms at all.
The study met all pre-specified secondary efficacy endpoints for omalizumab 300mg and150 mg compared to placebo, except the 150mg group did not reach statistical significance versus placebo for the quality of life measurement at week 12.
On the safety side, the incidence and severity of adverse events (AEs) was similar across all ASTERIA I treatment groups; five omalizumab patients experienced serious AEs during the treatment period compared to four in the placebo group, and no deaths were reported during the study.
The drug was submitted to regulators on both sides of the pond during the third quarter.