Infectious Disease

The FDA approves the self-injectable formulation of Xolair

April 12, 2021

1 min read

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According to the manufacturer, the FDA has approved a self-injectable formulation of Xolair for suitable patients with moderate to severe persistent allergic asthma, nasal polyps or chronic idiopathic urticaria.

“Expanding treatment options for personalized care and self-management is always welcome news for the patient community.” Kenneth Mendez, CEO and President of the Asthma and Allergy Foundation of America said in a press release. “The ability to deliver FDA-cleared treatment outside of the healthcare provider’s office, but still being managed by that healthcare provider, can reduce barriers to care for patients and their caregivers.”

According to the manufacturer, the FDA has approved a self-injectable formulation of omalizumab for all indications.
Photo source: Adobe Stock.

Xolair (omalizumab, Genentech and Novartis) is a biological agent that has been approved in the US since 2003, according to press releases from the manufacturers. It is used to treat moderate to severe persistent asthma in patients 6 years of age and older whose condition is not well controlled with inhaled corticosteroids. Nasal polyps in patients aged 18 years and over whose condition is not well controlled with nasal corticosteroids; and chronic idiopathic urticaria in patients 12 years of age and older whose condition is not well controlled with treatment with H1 antihistamine.

The self-injectable formulation is indicated for patients with no history of anaphylaxis. Before they can self-administer the pre-filled syringe, according to the press releases, providers must examine patients for hypersensitivity after at least three injections in the healthcare sector. Once the safety has been determined, the provider can determine whether the self-injectable formulation is appropriate for the patient. In this case, the provider must train the patient or caregiver to give the injection outside of a healthcare setting, identify signs of anaphylaxis, and manage the anaphylaxis appropriately.

References:

Business Wire. The FDA approves a pre-filled Xolair (omalizumab) syringe for self-injection for all indications. https://www.prnewswire.com/news-releases/novartis-receives-fda-approval-of-xolair-omalizumab-self-injection-with-prefilled-syringe-across-all-indications-for-eigniate-patients- 301266937.html. Accessed April 12, 2021.

PR Newswise. Novartis receives FDA approval to self-inject Xolair (omalizumab) with a pre-filled syringe for all indications for eligible patients. https://www.prnewswire.com/news-releases/novartis-receives-fda-approval-of-xolair-omalizumab-self-injection-with-prefilled-syringe-across-all-indications-for-eigniate-patients- 301266937.html. Accessed April 12, 2021.

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Stephen H. Kimura, MD

I believe that patients who have been given Xolair safely in a medical setting should be able to self-administer Xolair. This is addressed in the press release, which says that patients with no history of anaphylaxis and three office doses can be trained to self-manage at home. In my experience, this can be done safely and I have not seen any cases of anaphylaxis in the hundreds of patients I have started on Xolair.

In this way I can relieve employees of Xolair injections in the office if they are already overwhelmed with the administration of allergen immunotherapies and other biological agents. This also enables our patients who travel from great distances to shorten their commute to our office.

During this pandemic, many of these patients are also suspicious of going into public places and spending 30 minutes after an injection. This would enable them to manage Xolair in the security of their own four walls.

Stephen H. Kimura, MD

Specialist in allergy and immunology,

West Florida Medical Center Clinic,

Pensacola, Fla.

Disclosure: Kimura does not report any relevant financial information.

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Vincent C. Tubiolo, MD, FAAAAI)

Vincent C. Tubiolo, MD, FAAAAI

The availability of Xolair for self-administration at home makes it easier for many patients with asthma, hives and nasal polyps to treat them. We know this drug is effective and safe to use. The COVID-19 pandemic has made it difficult for many patients to get treatment in an office due to travel and social distancing. Some competing drugs that also treat asthma and require injections are already available for home use. Xolair has a long history of safety and effectiveness. Having this available for self-administration at home will make a big difference in my opinion for multiple patients and improve compliance.

Vincent C. Tubiolo, MD, FAAAAI

Specialist in allergy, asthma and immunology,

Allergy, Asthma and Immunology Care Center,

Santa Barbara, California

Disclosure: Tubiolo does not report any relevant financial information.

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