Xolair gets FDA approval for skin condition
pharmafile | March 24, 2014 | News story | Research and Development, Sales and Marketing | FDA, Novartis, Roche, Sanofi, Xolair, chronic hives, csu
An asthma drug developed by Roche subsidiary Genentech and Novartis has been granted an additional indication to treat chronic hives in the US.
The FDA decision comes just weeks after Xolair (omalizumab) earned a similar licence extension in the EU for use in combination with antihistamines.
The injectable drug can now be used to treat chronic spontaneous urticaria (CSU), a disease characterised by severe outbreaks of hives that can last for months or even years.
Xolair’s US approval was based on two Phase III trials which showed it significantly reduced itching and the appearance of hives, compared to placebo, among a cohort of over 600 patients aged between 12 and 75 years.
Previously, H1-antihistamines were the only approved treatment for the condition but their effectiveness was limited to around 50% of patients, according to Novartis and Roche.
Roche’s chief medical officer Sandra Horning, describes CSU as “difficult to manage because its causes are unknown, and other approved medicines aren’t effective enough for many patients.”
She adds: “We are pleased to have Xolair as a new option for people with this serious skin condition.” And Horning’s satisfaction is certain to be shared across the board at Roche and Novartis as the new indication is set to top-up the $613 million Xolair brings in yearly for asthma, by an estimated $500 million according to FiercePharma.
Novartis executives will be particularly pleased as dermatology represents a major area of interest for the firm. In 2012, its generics subsidiary Sandoz acquired Fougera in a deal worth more than $1.5 billion, making it the world’s biggest dermatology generics firm.
Novartis’ psoriasis treatment secukinumab is also undergoing regulatory evaluation after promising late-stage trial data as emerged last summer. Analysts at Datamonitor predict sales of around $250 million by 2020 should the skin drug make it to market this year.
Xolair was first approved for severe allergic asthma in 2003 in the US, and two years later in the UK. It has enjoyed steady sales growth in the intervening years.
The drug tackles CSU by binding to an antibody known as immunoglobulin E and inhibiting the skin reactions that lead to the formation of hives. The precise mechanism of action underlying its efficacy is unclear and remains under investigation.
CSU, known as chronic idiopathic urticaria in the US, is estimated to affect up to 1% of the global population at any given time, according to research cited by Novartis.
Hugh McCafferty
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