FDA Updates for Allergies & Asthma

FDA Updates for Allergies & Asthma

FDA Grants First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure
The US Food and Drug Administration approved Genentech’s Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods. People who take Xolair must continue to avoid foods they are allergic to. Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Xolair was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients. Xolair is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” said Kelly Stone, MD, PhD, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”  

According to the Centers for Disease Control and Prevention, almost 6% of people in the United States in 2021 had a food allergy and exposure to the particular food(s) to which they are allergic can lead to potentially life-threatening allergic reactions (i.e., anaphylaxis). There is currently no cure for food allergy. Current treatment requires strict avoidance of the food(s) the patient is allergic to, and prompt administration of epinephrine to treat anaphylaxis should accidental exposures occur. Palforzia (peanut allergen powder) is an oral immunotherapy product approved in patients 4-17 years of age for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut, but its benefits are restricted to peanut allergy. Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.

Xolair is a drug (in the class of drugs called monoclonal antibodies) that binds to immunoglobulin E (IgE), the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors.

The key secondary measures of efficacy were the percentage of subjects who were able to consume a single dose (1,000 milligrams or greater) of cashew, milk or egg protein without moderate to severe allergic symptoms at the end of the 16-to-20-week treatment course. For cashew, 42% (27 of 64 subjects) who received Xolair achieved this endpoint compared to 3% (1 of 30 subjects) who received placebo. For milk, 66% (25 of 38 subjects) who received Xolair achieved this 

Xolair is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis. Xolair received Priority Review and Breakthrough Therapy designations for this indication. (February 2024) 


First and Only Rescue Medication Approved for As-needed Use to Reduce Risk of Asthma Exacerbations  
AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, has been approved by the FDA for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.

Airsupra is a first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS) in the US. It is being developed by AstraZeneca and Avillion.

Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said: “People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. The approval of Airsupra means that for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease.” (January 2023)

FDA Approves First Generic of Symbicort to Treat Asthma and COPD
The US Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). Two inhalations, two times a day (usually morning and night, about 12 hours apart), treat both diseases by preventing symptoms, such as wheezing for those with asthma, and by helping with better breathing, for those with COPD. The inhaler is approved for two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation).

The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, Inc. (March 2022)

FDA Approves First Generic of Restasis
The FDA has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) to Mylan Pharmaceuticals 0.05% single-use vials (eye drops) to increase tear production in people whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Increased tear production was not seen in people currently taking topical anti-inflammatory drugs or using punctal plugs.

“Restasis has been approved for use in the US for nearly 20 years, but until today, there was no approved generic product of this drug that can help the millions of Americans who suffer from dry eyes,” said Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Today’s approval reflects the FDA’s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts. Supporting development and expanding opportunities to bring complex generic drugs to the market is a major focus of our efforts to help improve competition and help lower drug prices.”

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Keratoconjunctivitis sicca, or dry eye, happens when a person’s eyes don’t make enough tears to stay wet, or when the tears are not of the correct consistency. This condition, affecting millions of Americans each year, can make the eyes feel uncomfortable. Cyclosporine ophthalmic emulsion is a commonly prescribed immunomodulator (affects the functioning of the immune system) with anti-inflammatory effects that generally helps to increase tear production in these patients. (February 2022)

FDA Approval of Xolair® for Adults with Nasal Polyps
The US Food and Drug Administration (FDA) has approved Novartis’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation.

“With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal polyps in two pivotal Phase III studies,” said Joseph Han, MD, Chief of the Division of Rhinology and the Division of Allergy at Eastern Virginia Medical School and study investigator of the POLYP 1 and POLYP 2 trials. “Xolair provides a new option for treating these patients, who often have other respiratory and allergic conditions that may further worsen symptoms.”

“This approval is welcome news for people with nasal polyps and adds to the legacy of Xolair for treating multiple debilitating IgE-mediated conditions,” said Victor Bultó, President, Novartis Pharmaceuticals Corporation. “The additional indication is an important step on our path to realizing the full potential of Xolair across allergic, respiratory and inflammatory conditions and associated comorbidities.”

“Adults living with nasal polyps may not be able to breathe through their nose and smell normally, and currently have limited treatment options,” said Tonya Winders, President and CEO, Allergy & Asthma Network. “The approval of Xolair is welcome news for the community, providing another option to treat patients and help alleviate their symptoms.”

Xolair is an injectable biologic medicine that is also FDA-approved for the treatment of moderate to severe persistent allergic asthma in people 6 years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines. In the US, Novartis Pharmaceuticals Corporation and Genentech work together to develop and co-promote Xolair. (December 2020)