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U.S. FDA Approves Label Expansion for ALK's ODACTRA® (House Dust Mite Allergen Tablet) for Sublingual Use as Immunotherapy to Now Include Children with House Dust Mite Allergy
- ODACTRA is now indicated to treat house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, in children ages 5 through 11 years, in addition to patients 12 through 65 years of age –
- House dust mites are a common cause of allergies in children and can cause symptoms year-round1 -
BEDMINSTER, N.J., Feb. 28, 2025 /PRNewswire/ -- ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the U.S. Food and Drug Administration (FDA) expanded its indication of ODACTRA® (House Dust Mite Allergen Tablet) for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, to now include children ages 5 through 11 years, in addition to patients 12 through 65 years of age.2
ODACTRA is an allergy immunotherapy indicated to treat HDM-induced allergic rhinitis and is administered sublingually as a small tablet that dissolves under the tongue. Having this option available for parents with children who meet the treatment requirements is so important, as many children at this age can have a challenging time with other prescription allergy treatment options that require regular injections.
(PRNewsfoto/ALK, INC.)
Jackie Eghrari-Sabet M.D., Allergist & Immunologist and Clinical Assistant Professor at the George Washington University School of Medicine, said: "The pediatric indication for ODACTRA is significant because it provides physicians and parents a new option for treating these younger patients. In addition to the convenience of sublingual administration, ODACTRA has been shown to reduce their allergy symptoms and reliance on symptomatic medications. Allergy symptoms such as nasal congestion, sneezing, and watery eyes, can have a significant impact on a child's life."
Largest Pediatric Trial for House Dust Mite Allergy
The approval was based, in part, on data from a Phase 3 clinical trial in 1,458 children ages 5 through 11 years old and is the largest pediatric trial of any HDM allergen immunotherapy in children published to date. This randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of ODACTRA in children ages 5 through 11 years with a clinical history of physician-diagnosed HDM-induced allergic rhinitis/conjunctivitis (AR/C) for at least one year with or without a clinical history of asthma, and persistent allergic rhinitis symptoms despite receiving symptom-relieving medication. Both the ODACTRA and placebo groups were allowed to take symptom-relieving allergy medications (including oral and ocular antihistamines and nasal corticosteroids) during the study as needed. The primary efficacy endpoint was assessment of change in total combined rhinitis score (TCRS) during the final eight weeks of the one-year treatment period.2 TCRS is a research measure that is a combination of the daily rhinitis symptom score and the daily medication score. The World Allergy Organization proposed clinically relevant efficacy as ≥ 20% difference between active and placebo in clinical endpoints that include symptom score and/or daily medication use.3
In the study, children treated with ODACTRA (n=693) experienced a relative reduction in TCRS of 22% (95% CI: 12.0; 31.1) versus placebo (n=706). The safety profile in the study was consistent with the established safety profile for adults and adolescents. Most adverse events (AEs) were mild or moderate. Among the evaluable safety population, ODACTRA (n=727) and placebo (n=731), four patients in the ODACTRA group experienced severe treatment-related AEs (TRAEs) which included oral pruritus (itching), ear pruritus, glossodynia (burning pain in the mouth), lip swelling, and abdominal pain. Across both treatment groups, 1.8% of participants discontinued the study due to an AE while exposed to ODACTRA.2 No participants ages 5 through 11 years treated with ODACTRA reported treatment-related serious AEs, treatment-related anaphylaxis, or AEs requiring treatment with epinephrine. The three most frequent TRAEs, reported in at least 2% of subjects in the ODACTRA group, were local application-site reactions including oral pruritus, throat irritation, and ear pruritus.2
The full results were published in the peer-reviewed publication, The Lancet Regional Health – Europe.
Judit Nyirady, MD, MBA, SVP, Global Chief Medical Office, ALK, added: "With the expanded pediatric approval of ODACTRA in the U.S., younger children can now be treated with a sub-lingual tablet, in addition to adolescent and adult patients, who experience allergy symptoms due to house dust mites. We are proud to build upon our longstanding commitment to patients developing evidence-based innovative medications like ODACTRA and continue our 100-year legacy of pioneering in the field of respiratory allergies."
About Sublingual Allergy Immunotherapy (SLIT)-Tablets
Allergy immunotherapy, or AIT, treats the underlying cause of environmental allergies using a person's own immune system. Small amounts of allergens are introduced into the body so the immune system can gradually learn to tolerate them better. It targets the specific allergy trigger that causes the immune system to overreact and provides long-lasting improvement for years after treatment. SLIT-tablets are prescription medications that dissolve under the tongue and are taken once-daily at home, after the first dose is taken at the doctor's office.4,5 SLIT-tablets offer an alternative treatment option for eligible patients who prefer to avoid allergy treatments administered through subcutaneous injection.
For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media (ALK headquarters): Maiken Riise Andersen, tel. +45 5054 1434 Media: (ALK North America): Dan Commerford, tel. +1 908 842 8355
ODACTRA Indication
ODACTRA®(House Dust Mite Allergen Tablet) is an allergen extract indicated as immunotherapy for the treatment of house dust mite (HDM)–induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in individuals 5 through 65 years of age. ODACTRA is not indicated for the immediate relief of allergic symptoms.
Selected Important Safety Information about ODACTRA
What is the most important information I should know about ODACTRA?
ODACTRA can cause severe allergic reactions that may be life-threatening. If any of these symptoms occur, stop taking ODACTRA and immediately seek medical care:
Trouble breathing
Throat tightness or swelling
Trouble swallowing or speaking
Dizziness or fainting
Rapid or weak heartbeat
Severe stomach cramps or pain, vomiting, or diarrhea
Severe flushing or itching of the skin
For home administration of ODACTRA, your doctor will prescribe epinephrine, a medicine you can use if you or your child has a severe allergic reaction after taking ODACTRA. Your doctor will train and instruct you on the proper use of epinephrine.
If you or your child forgets to take ODACTRA, do not take two tablets. Take the next tablet at your normal scheduled time the next day. If you or your child misses more than one dose of ODACTRA, contact your healthcare provider before restarting.
Do not take ODACTRA if you or your child:
has severe, unstable or uncontrolled asthma
had a severe allergic reaction in the past that included any these symptoms: trouble breathing, dizziness or fainting, rapid or weak heartbeat
has ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before
has ever been diagnosed with eosinophilic esophagitis
is allergic to any of the inactive ingredients contained in ODACTRA. The inactive ingredients contained in ODACTRA are gelatin, mannitol, and sodium hydroxide.
Your doctor may decide that ODACTRA is not the best treatment if you or your child:
has asthma, depending on how severe it is
suffers from lung disease such as chronic obstructive pulmonary disease (COPD)
suffers from heart disease such as coronary artery disease, an irregular heart rhythm, or you have hypertension that is not well controlled
is pregnant, plans to become pregnant during the time you will be taking ODACTRA, or is breast-feeding
is unable or unwilling to administer epinephrine to treat a severe allergic reaction to ODACTRA
is taking certain medicines that enhance the likelihood of a severe reaction or interfere with the treatment of a severe reaction. These medicines include:
Beta blockers and alpha-blockers (prescribed for high blood pressure)
Cardiac glycosides (prescribed for heart failure or problems with heart rhythm)
Diuretics (prescribed for heart conditions and high blood pressure)
Ergot alkaloids (prescribed for migraine headache)
Monoamine oxidase inhibitors or tricyclic antidepressants (prescribed for depression)
Thyroid hormone (prescribed for low thyroid activity)
is receiving allergy shots or other immunotherapy under the tongue. Use of more than one of these types of medicines together may increase the likelihood of a severe allergic reaction
Stop taking ODACTRA and contact your doctor if you or your child has any mouth surgery procedures (such as tooth removal), develops any mouth infections, ulcers or cuts in the mouth or throat, or has heartburn, difficulty swallowing, pain with swallowing, chest pain that does not go away or worsens, asthma or any other breathing condition that gets worse, or any type of serious allergic reaction.
The most commonly reported side effects were throat irritation/tickle, itching in the mouth or ears, swelling of the back of the mouth, lips or tongue, tongue pain, nausea, throat swelling, stomach pain, tongue ulcer/sore on the tongue, and mouth ulcer/sore in the mouth, diarrhea, vomiting, and food tastes different. These side effects, by themselves, were not dangerous or life-threatening. Typically, these common side effects begin within the first week of starting ODACTRA and may reoccur for up to two weeks. These common side effects experienced after taking the first tablet typically last up to one hour.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About ALK ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.
References
1 InformedHealth.org. Overview: Dust mite allergies. Institute for Quality and Efficiency in Health Care (IQWiG). Available at: https://www.ncbi.nlm.nih.gov/books/NBK447098/. Accessed February 24, 2025. 2 ODACTRA. Prescribing information. ALK-Abelló, Inc.; Rev. 2025. 3 A. Schuster, D. Caimmi, H. Nolte, et al. Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial The Lancet Regional Health - Europe, Volume 48, 2025, 101136, ISSN 2666-7762. 4 Mayo Clinic. Allergy medications: Know your options. Available at: https://www.mayoclinic.org/diseases-conditions/allergies/in-depth/allergy-medications/art-20047403. Accessed February 14, 2025. 5 Gunawardana NC and Durham SR. New approaches to allergen immunotherapy. Ann Allergy Asthma Immunol. 2018;121(3):293-305.
