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FDA approves new self-injection administration for Xolair

Drug is approved for asthma and other allergic and inflammatory conditions

The US Food and Drug Administration (FDA) has approved a new self-injection administration option for Novartis and Genentech’s immunoglobulin E (IgE) blocker Xolair.

The FDA has approved the biologics licence application (BLA) for Xolair (omalizumab) prefilled syringe for self-injection across all approved indications in the US.

This includes a number of allergic and inflammatory conditions, including moderate-to-severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.

Patients must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity before starting the new Xolair self-injection administration route.

Healthcare providers are also required to train patients or caregivers on the correct injection technique, as well as how to recognise the signs and symptoms of anaphylaxis and how to treat it before self-injection can take place outside the healthcare setting.

“Today's approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions,” said Levi Garraway, chief medical officer and head of global product development at Roche.

“Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic,” he added.

Earlier this year, Novartis announced that the FDA granted its Xolair follow-up ligelizumab a breakthrough therapy designation for the treatment of CIU – also known as chronic spontaneous urticaria (CSU) – in patients who have experienced an inadequate response to H1-antihistamine treatment.

Ligelizumab binds to immunoglobulin E (IgE), a key driver of the condition, with a mechanism of action that has demonstrated superior effectiveness at inhibiting this pathogenic pathway when compared to Xolair.

According to Novartis, ligelizumab binds to IgE with an 88-fold higher affinity than Xolair, with the two binding differently to the antibody.

“We were recently encouraged by previous clinical study results showing more patients are completely symptom-free from CSU with ligelizumab than Xolair,” said Eric Hughes, global development unit head for immunology, hepatology and dermatology, Novartis.

“This mechanistic study further supports those findings as we look to reimagine care to bring better treatment options for patients with CSU,” he added.

Novartis picked up ligelizumab following its acquisition of UK firm Ziarco in 2016. Although financial details were not disclosed, analysts suggested that the deal could be valued at up to $1bn.

Article by
Lucy Parsons

13th April 2021

From: Regulatory



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