Omalizumab is effective and safe for CSU – Study

A Novartis logo is pictured on its headquarters building in MumbaiDrugmaker Novartis announced Saturday that its drug omalizumab was twice as effective as compared to a placebo in treating chronic spontaneous urticaria (CSU), a severe form of hives.

The Swiss company cited results from the Phase III of ASTERIA I study which established omalizumab to be an effectual and safe drug for CSU.

For the purpose of the study, the company analyzed the weekly Itch Severity Score (ISS) of the participants.

Study Results

The ASTERIA I study revealed that participants who were administered 300 mg dose of omalizumab responded as early as Week 1 as compared to the participants in the control group who took as much as a month to respond.

By Week 12, all three omalizumab doses of 300 mg, 150 mg and 75 mg proved effective in improving patients’ weekly ISS considerably.

The 300 mg dose of omalizumab also led to nearly twice improvement in the quality of life of patients as compared to those on a placebo by Week 12. By the end of the said period 36 percent of the patients on the 300 mg dose reported the absence of all symptoms.

A considerable decline in deep tissue swelling, known as angioedema was also witnessed in patients on 300 mg dosage. No deaths were reported during this study.

Novartis declared that the latest findings corroborated earlier results obtained from pivotal Phase III registration studies; ASTERIA II and GLACIAL – of omalizumab in CSU.

Tim Wright, Global Head of Development, Novartis Pharmaceuticals said, “The positive new data clearly show the potential of omalizumab to treat CSU, a disease where more than 50% of patients don’t respond to approved doses of antihistamines, the only licensed treatment option.”

The Swiss company had filed applications for the approval of omalizumabas as a treatment for CSU to the heath authorities in the United States and the European Union.

Also known as Xolair, Omalizumab is already approved for the treatment of severe asthma.

The results of the study were presented at the 22nd Congress of the European Association of Dermatology and Venereology or EADV in Istanbul, Turkey.