FDA Approves Omalizumab for Self-Injection Across All Indications


Omalizumab (Xolair; Genentech) is approved as a prefilled syringe for self-injection for certain patients with asthma, nasal polyps, and chronic hives.


The FDA has given the green light to omalizumab (Xolair; Genentech) prefilled syringe for self-injection across all approved indications.

The approval offers health care professionals and their patients increased flexibility for certain allergic and inflammatory conditions, according to Genentech.

Omalizumab is the only FDA-approved antibody that works to target and block immunoglobulin E (IgE) and down-regulating high-affinity IgE receptor and limiting mast cell degranulation in order to treat moderate to severe persistent allergic asthma, chronic urticaria (CIU), and nasal polyps.

The agency has approved omalizumab for self-injection for the following indications.

  • Moderate to severe persistent asthma in individuals 6 years of age and older whose asthma symptoms are not well controlled with inhaled corticosteroids. A skin or blood test is performed to see if individuals have allergies to year-round allergens.
  • Nasal polyps in those 18 years of age and older if nasal corticosteroids were shown to be ineffective in the patient.
  • CIU (chronic hives without a known cause) in individuals 12 years of age and older whose hives are not controlled with H1 antihistamine treatment.

Patients starting treatment with omalizumab will receive omalizumab first by a health care provider, who will determine whether the patient or a caregiver should give the prefilled syringe injections. Patients and/or their caregivers must also be taught the signs and symptoms, and treatment, of anaphylaxis.

Omalizumab was initially approved by the FDA in 2003; an estimated 460,000 patients have received treatment with the drug. The most recent indication was based on a clinical development program that included 10 phase 3 studies.

In adults and children 12 years of age and older with asthma, the most frequently reported adverse effects (AEs) are joint pain, particularly in the arms and legs, dizziness, fatigue, itching, skin rash, bone fractures, and pain or discomfort of the ears.

For children between the ages of 6 and 12 with asthma, the most common AEs are swelling of the inside of the nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.

Adult patients with nasal polyps most often experience headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.

The most common AEs for individuals with CIU include nausea, headaches, swelling of the inside of the nose, throat, or sinuses, cough, joint pain, and upper respiratory tract infection.

“Expanding treatment options for personalized care and self-management is always welcome news for the patient community,” said Kenneth Mendez, CEO and president, Asthma and Allergy Foundation of America. “The possibility of administering FDA-approved treatment outside of the healthcare provider’s office, but still guided by that healthcare provider, may reduce barriers to care for patients and their caregivers.”


  1. FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications. News Release. Genentech; April 12, 2021. Accessed April 12, 2021. https://www.gene.com/media/press-releases/14904/2021-04-12/fda-approves-xolair-omalizumab-prefilled.

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