FDA approves self-injectable formulation of Xolair
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The FDA has approved a self-injectable formulation of Xolair for appropriate patients with moderate to severe persistent allergic asthma, nasal polyps or chronic idiopathic urticaria, according to the manufacturers.
“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 possibility of administering FDA-approved treatment outside of the health care provider’s office, but still guided by that health care provider, may reduce barriers to care for patients and their caregivers.”
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Xolair (omalizumab, Genentech and Novartis) is a biologic agent that has been approved in the United States since 2003, according to press releases from the manufacturers. It is used to treat moderate to severe persistent asthma in patients aged 6 years and older whose condition is not well-controlled with inhaled corticosteroids; nasal polyps in patients aged 18 years and older whose condition is not well-controlled with nasal corticosteroids; and chronic idiopathic urticaria in patients aged 12 years and older whose condition is not well-controlled with H1 antihistamine treatment.
The self-injectable formulation is indicated for patients with no previous history of anaphylaxis. Before they can self-administer the prefilled syringe, providers must observe patients for hypersensitivity after at least three injections in a health care setting, according to the press releases. After safety has been established, the provider can determine whether the self-injectable formulation is appropriate for the patient. If so, the provider must train the patient or caregiver how to administer the injection outside a health care setting, identify signs of anaphylaxis and appropriately treat anaphylaxis, the releases said.
References:
Business Wire. FDA approves Xolair (omalizumab) prefilled syringe for self-injection across all indications. https://www.prnewswire.com/news-releases/novartis-receives-fda-approval-of-xolair-omalizumab-self-injection-with-prefilled-syringe-across-all-indications-for-appropriate-patients-301266937.html. Accessed April 12, 2021.
PR Newswise. Novartis receives FDA approval of Xolair (omalizumab) self-injection with prefilled syringe across all indications for appropriate patients. https://www.prnewswire.com/news-releases/novartis-receives-fda-approval-of-xolair-omalizumab-self-injection-with-prefilled-syringe-across-all-indications-for-appropriate-patients-301266937.html. Accessed April 12, 2021.
Perspective
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Stephen H. Kimura, MD, FAAAAI
I believe that allowing patients who have been safely administered Xolair in a medical setting should have the option to self-administer Xolair. This is addressed in the news release saying the patients with no history of anaphylaxis and three doses administered in the office can be trained to self-administer at home. From my experience, this can be safely done, and I have not seen any cases of anaphylaxis in the hundreds of patients I have started on Xolair.
This will allow me to free up staff from giving Xolair injections in the office when they are already overwhelmed with administering allergen immunotherapy as well as other biologic agents. This also allows our patients who travel from long distances to cut down on their commute to our office.
During this pandemic, many of these patients are also leery about going into public spaces and spending 30 minutes after an injection. This would allow them to administer Xolair in the safety of their own homes.
Perspective
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Vincent C. Tubiolo, MD, FAAAAI
Having Xolair available for self-administration at home will ease the treatment for many patients with asthma, hives and nasal polyps. We know that this drug is effective and can be administered safely. The COVID-19 pandemic has made it more difficult for many patients to receive treatments in an office setting due to travel and social distancing. Some competitor drugs that also treat asthma and require injections are already available for use at home. Xolair has a long safety and efficacy history and having this available for self-administration at home will make a big difference for several patients and improve compliance, in my opinion.
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