FDA-Approved Biologics for Asthma, Allergies and Eczema

Name: FDA-Approved Biologics for Asthma, Allergies and Eczema
Published: Oct 10 2022

The biologic medications listed on this webpage are approved by the U.S. Food and Drug Administration (FDA). They are indicated for:

Moderate to severe asthma
Eosinophilic asthma
COPD with eosinophilic type
Moderate to severe atopic dermatitis (eczema)
Food allergies
Severe chronic rhinosinusitis with nasal polyps
Eosinophilic esophagitis (EoE)
Eosinophilic granulomatosis with polyangiitis (EGPA)
Chronic urticaria (hives)
Certain digestive diseases

Ask your doctor if one of these biologic therapies is right for you or your child.

Allergy & Asthma Network provides this information to help you learn about biologic medications. Only your healthcare provider can diagnose a medical condition and prescribe a biologic treatment.

Biologic	Candidates for Treatment	How It Works	How It’s Administered
Benralizumab (Fasenra®)	Adults and children ages 12 years and older who have severe asthma with an eosinophilic phenotype	Benralizumab blocks the interaction of the protein interleukin-5 (IL-5) with cell surface receptors. IL-5 activates eosinophils, a type of white blood cell, that cause inflammation in the airways. The drug reduces airway inflammation. This can result in reduced asthma symptoms, including difficulty breathing, and fewer asthma attacks.	The biologic treatment is given as an injection under the skin. It could be in the upper arm, thigh, or stomach. The medication must be delivered in the tissue between the skin and the muscle. Guidelines recommend that people prescribed benralizumab start by getting the injection every four weeks, then every eight weeks. A doctor may give the biologic treatment in the office or clinic. You may be able to self-administer it at home with a pre-filled auto-injector.
Dupilumab (Dupixent®)	Adults and children ages 6 years and older who have moderate to severe eosinophilic asthma or who depend on oral corticosteroids to treat their asthma Adults with inadequately controlled COPD with an eosinophilic phenotype Adults and children ages 6 months and older with moderate-to-severe atopic dermatitis that isn't well controlled with other treatments Adults and children ages 12 years and older with chronic spontaneous urticaria that is not well controlled with H1 antihistamine treatment. Adults and children ages 1 and older with eosinophilic esophagitis People ages 18 years and older with severe chronic rhinosinusitis with nasal polyps that are not well controlled	Dupilumab blocks the proteins interleukin-4 and interleukin-13 (IL-4 and IL-13) from interacting with cell surface receptors. The drug can prevent inflammation in the airways and on the skin.	Dupilumab is given as an injection under the skin. It could be in the upper arm, thigh, or stomach. The drug must be delivered in the tissue between the skin and the muscle. The first dose is given as two injections under the skin. After that, it's one injection. This might be every 2-4 weeks or every four weeks, depending on your age and weight. A doctor may give dupilumab in the office or clinic. You may be able to self-administer it at home with a pre-filled auto-injector.
Lebrikizumab (Ebglyss™)	Adults and children ages 12 and older who weigh at least 88 pounds and have moderate to severe atopic dermatitis that is not adequately controlled with topical prescription therapies	Lebrikizumab works by blocking the protein interleukin-13 (IL-13) from binding to cell receptors. This disrupts the process that causes skin inflammation. It helps keep skin symptoms under control.	Lebrikizumab is given as an injection under the skin. The injection site could be in the upper arm, thigh, or stomach. The medication is delivered in the tissue between the skin and the muscle. The initial loading dose is 500 mg (two 250 mg injections), followed by one 250 mg injection every 2 weeks thereafter, through 16 weeks. The maintenance dose is 250 mg every 4 weeks. A doctor may give lebrikizumab in the office or clinic. Adults may be able to self-administer it at home using a pre-filled auto-injector.
Mepolizumab (Nucala®)	Adults and children ages 6 years and older who have poorly controlled asthma or severe asthma with an eosinophilic phenotype People ages 18 years and older with severe chronic rhinosinusitis with nasal polyps that isn't well controlled People ages 18 years and older who have Eosinophilic Granulomatosis with Polyangiitis (EGPA) Adults and children ages 12 years and older who have Hypereosinophilic syndrome for 6 months or less without a known secondary cause	Mepolizumab blocks the interaction of the protein interleukin-5 (IL-5) with cell surface receptors. IL-5 activates eosinophils, a type of white blood cell, that cause inflammation. The drug can reduce the risk of flare-ups and symptoms.	Mepolizumab is given as an injection under the skin. It could be in the upper arm, thigh, or stomach. The biologic therapy must be delivered in the tissue between the skin and the muscle. Guidelines recommend that people prescribed this medicine have the injection every four weeks. A doctor may give mepolizumab in the office or clinic. You may be able to take it at home with a pre-filled auto-injector.
Nemolizumab (Nemluvio®)	Adults and children 12 years of age or older with moderate to severe atopic dermatitis, used in combination with topical corticosteroids or topical calcineurin inhibitors, when eczema symptoms are not well controlled with topical therapies.	Nemolizumab blocks the interaction of the protein interleukin-31 (IL-31). This neutralizes IL-31 by keeping it from sending the signals that trigger itching and inflammation. The drug can significantly reduce itch symptoms and inflammation, allowing time for the skin to heal.	Nemolizumab is given as an injection under the skin between the skin tissue and the muscle. The injection site can be the thigh, stomach or back of the upper arm. Injection in the back of the upper arm should only be done by a caregiver or healthcare professional. The loading dose is 60 mg (two 30 mg injections). This is followed by a maintenance dose of 30 mg given every four weeks. After the loading dose and four months of injections, patients with have clear or almost-clear skin can take the 30 mg dose every eight weeks. A doctor may give the biologic in the office or clinic. You may be able to self-administer it at home using a pre-filled auto-injector pen.
Omalizumab (Xolair®)	Adults and children ages 6 years and older who have moderate to severe allergic asthma that isn't well controlled with other treatments People ages 18 years and older with severe chronic rhinosinusitis with nasal polyps that isn't well controlled with other treatments Adults and children ages 12 years and older with chronic spontaneous urticaria (hives) who still have symptoms despite H1 antihistamine treatment Adults and children ages 1 year and older who have a severe food allergy. The goal of treatment is to better tolerate food allergen(s) in case of accidental exposure. This would also lower the risk of an allergic reaction	Omalizumab stops the binding of IgE, or Immunoglobulin E, to mast cells and basophils. IgE is a protein called an antibody. It plays a role in the allergic response to an allergen by starting the inflammatory process. Basophils and mast cells are white blood cells that are part of the immune system. They release histamine. The drug can prevent the release of histamine and stop inflammation.	Omalizumab is given as an injection under the skin. It could be in the upper arm, thigh, or stomach. The medication must be delivered in the tissue between the skin and the muscle. Guidelines recommend that people prescribed this medicine have the injection every 2 to 4 weeks. A doctor may give omalizumab in the office or clinic. You may be able to self-administer it at home with a pre-filled auto-injector.
Reslizumab (Cinqair®)	People ages 18 years and older who have poorly controlled asthma with other medicines (such as an inhaled corticosteroid)	Reslizumab blocks the signaling of the protein interleukin-5 (IL-5) with cell surface receptors. The drug prevents the production and survival of eosinophils, a white blood cell in your immune system. This can reduce airway inflammation and the risk of asthma exacerbations.	The drug is given as an infusion. This is a method of putting drugs right into the bloodstream. It's administered by a healthcare provider in a healthcare setting or at home. Reslizumab is given once every four weeks. The infusion takes about 20-50 minutes.
Tezepelumab (Tezspire®)	Adults and children ages 12 years and older who have severe uncontrolled asthma, with no limitations on phenotype or biomarkers	Tezepelumab-ekko blocks thymic stromal lymphopoietin (TSLP). The airway releases TSLP, a protein, in response to asthma triggers. Blocking TSLP can prevent airway inflammation. Tezepelumab-ekko can reduce asthma symptoms, improve lung function, and improve overall well-being.	The drug is given as an injection under the skin. It could be in the upper arm, thigh, or stomach. The medication is delivered in the tissue between the skin and the muscle. It is usually given once every four weeks. A doctor may give tezepelumab-ekko in the office or clinic. Alternatively, you can self-administer it at home with a pre-filled auto-injector.
Tralokinumab (Adbry®)	Adults and children ages 12 years and older who have moderate to severe atopic dermatitis (eczema)	Tralokinumab works by blocking the protein interleukin-13 (IL-13) from binding to cell receptors. This disrupts the process that causes inflammation and keeps skin symptoms in check.	Tralokinumab is given as an injection under the skin. The injection site could be in the upper arm, thigh, or stomach. The medication is delivered in the tissue between the skin and the muscle. For adults, the initial loading dose is 600 mg, followed by 300 mg injections every two weeks. For children, the initial loading is 300 mg, followed by 150 mg injections every two weeks. A doctor may give tralokinumab in the office or clinic. You may be able to self-administer it at home using a pre-filled auto-injector.