EC approval for self-administration of Xolair

13 December 2018
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The European Commission (EC) has approved Xolair (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.

With this approval, Swiss pharma giant Novartis’ (NOVN: VX) Xolair is the first and only biologic to offer the option of self-administration for SAA and CSU, according to the company. The US Food and Drug Administration approved the self administration of Xolair for this indication in September this year.

Novartis’ sales of Xolair, which is co-promoted in the USA with Genentech, reached $920 million in 2017.

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