The EC approval is based on efficacy and safety record of Xolair in severe allergic asthma and chronic spontaneous urticaria
Novartis tower with surrounding buildings. (Credit: Novartis AG.)
Novartis has received the European Commission (EC) approval for Xolair (omalizumab) as an add-on therapy with intranasal corticosteroids (INC) to treat a type of severe chronic rhinosinusitis.
The European regulatory approval indicated Xolair in combination with INC for the treatment of severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients, aged 18 years and above, for whom INC therapy is not effective in controlling the disease.
The Swiss pharmaceutical firm said that in Phase 3 studies, treatment using Xolair has reduced nasal polyp size and improved symptoms and quality of life in CRSwNP patients.
The European Medicines Agency (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion recommending the approval of Xolair in June 2020.
The European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) academic director Lars Ingemann said: “People with chronic rhinosinusitis with nasal polyps can experience the significant quality of life impairment as a result of their symptoms.
“The symptoms include long-term nasal congestion and blockage, sleep disruption and loss of smell and taste. The EUFOREA patient advisory board welcomes today’s approval, which will provide an additional treatment option to patients with severe chronic rhinosinusitis with nasal polyps.”
Xolair is an anti-immunoglobulin E (IgE) antibody designed to treat CRSwNP
Xolair is said to be the first anti-immunoglobulin E (IgE) antibody treatment for CRSwNP, designed to specifically target and block IgE, which drives the inflammatory pathway of the disease.
The drug has been approved as an injectable prescription medicine to treat severe persistent allergic asthma in the US since 2003 and the EU since 2005, along with more than 100 countries in the world.
In addition, Xolair has been approved for the treatment of chronic spontaneous urticaria in more than 90 countries including the EU and in the US and Canada for chronic idiopathic urticaria (CIU).
A liquid formulation of the drug, in pre-filled syringes (PFS) has been approved in the EU and more than 20 other countries, including Canada, the US and Australia. The PFS prevents the need for procure Sterile Water for Injection (SWFI) and reconstitute Xolair before administering the medicine.
The drug was also approved for self-administration in pre-filled syringes in the EU in September 2018, followed by other countries, including Australia, Taiwan, Argentina and Brazil.
Novartis has partnered with Genentech, a Roche company, to develop and co-promote Xolair in the US. The company will market the product and record all sales and related costs outside of the US.