NEWS

Xolair-a biologic drug for asthma

Release time:

2018-03-09 02:06

Omalizumab (Xolair) is approved by the US FDA for the treatment of chronic idiopathic urticaria in patients ≥ 12 years of age who remain symptomatic after treatment with H1-antihistamines. The drug is marketed jointly by Roche and Novartis (Novartis).

Omalizumab was first approved for the treatment of moderate to severe asthma in 2003. In 2007, the FDA limited the use of the drug to a doctor's office to monitor for potential severe allergic reactions; a boxed warning was added. Omalizumab is the first biologic agent for the treatment of chronic idiopathic urticaria and the first drug approved for the treatment of chronic idiopathic urticaria after non-sedating H1-antihistamines.

The approval order was based on the results of two studies-the ASTERIA I and ASTERIA II5 studies, both presented at the annual meeting of the European Society of Dermatology and Venereology in November 2013.

Researchers say that about 1.5 million Americans are developing chronic idiopathic urticaria at any one time, and women are twice as likely to develop the disease as men.

Chronic idiopathic urticaria "can be a very difficult disease to treat". Patients may suffer from itching and urticaria for months or years. Xolair's new indication may bring hope for some patients to achieve satisfactory itching and urticaria relief.

Xolair(omalizumab) is an experimental monoclonal antibody that targets immunoglobulin E(IgE), which may inhibit histamine-induced skin reactions by reducing the downstream effects of IgE and cellular activation mechanisms.

At present, Xolair has been approved by many countries around the world and is listed under the brand name Sorel (Xolair) for the treatment of moderate to severe persistent allergic asthma. The drug is jointly developed by Novartis and Roche's Genentech (Genentech).