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
ALK (AKBLF) announced FDA approval for expanded indication of ODACTRA® to treat house dust mite-induced allergic rhinitis in children ages 5-11 years, extending from the previous 12-65 years age range. The approval stems from a landmark Phase 3 trial involving 1,458 children - the largest pediatric trial of house dust mite allergen immunotherapy to date.
The study demonstrated a 22% relative reduction in total combined rhinitis score versus placebo. ODACTRA is administered as a sublingual tablet, offering a convenient alternative to injection-based treatments. The safety profile aligned with adult/adolescent findings, with mostly mild to moderate adverse events. The most common treatment-related adverse events included oral pruritus, throat irritation, and ear pruritus, with no reported serious adverse events or anaphylaxis cases in the pediatric group.
ALK (AKBLF) ha annunciato l'approvazione da parte della FDA per l'indicazione ampliata di ODACTRA® nel trattamento della rinite allergica indotta dagli acari della polvere domestica nei bambini di età compresa tra 5 e 11 anni, estendendo l'intervallo di età precedente di 12-65 anni. L'approvazione deriva da uno studio clinico di Fase 3 fondamentale che ha coinvolto 1.458 bambini, il più grande trial pediatrico di immunoterapia agli allergeni da acari della polvere fino ad oggi.
Lo studio ha dimostrato una riduzione relativa del 22% nel punteggio totale combinato della rinite rispetto al placebo. ODACTRA viene somministrato come compressa sublinguale, offrendo un'alternativa conveniente ai trattamenti basati su iniezioni. Il profilo di sicurezza è risultato allineato con i risultati ottenuti negli adulti/adolescenti, con eventi avversi per lo più lievi o moderati. Gli eventi avversi più comuni correlati al trattamento includevano prurito orale, irritazione della gola e prurito auricolare, senza segnalazioni di eventi avversi gravi o casi di anafilassi nel gruppo pediatrico.
ALK (AKBLF) anunció la aprobación de la FDA para la indicación ampliada de ODACTRA® para tratar la rinitis alérgica inducida por ácaros del polvo en niños de 5 a 11 años, ampliando el rango de edad anterior de 12 a 65 años. La aprobación proviene de un ensayo de Fase 3 fundamental que involucró a 1,458 niños, el ensayo pediátrico más grande de inmunoterapia con alérgenos de ácaros del polvo hasta la fecha.
El estudio demostró una reducción relativa del 22% en la puntuación total combinada de rinitis en comparación con el placebo. ODACTRA se administra como un comprimido sublingual, ofreciendo una alternativa conveniente a los tratamientos basados en inyecciones. El perfil de seguridad se alineó con los hallazgos en adultos/adolescentes, con eventos adversos en su mayoría leves a moderados. Los eventos adversos más comunes relacionados con el tratamiento incluyeron prurito oral, irritación de la garganta y prurito en los oídos, sin reportes de eventos adversos graves ni casos de anafilaxis en el grupo pediátrico.
ALK (AKBLF)는 ODACTRA®의 FDA 승인을 발표했습니다. 이는 5세에서 11세 사이의 어린이의 집먼지 진드기 유발 알레르기 비염 치료를 위한 적응증을 확장한 것입니다. 이는 이전의 12세에서 65세까지의 연령 범위를 확장한 것입니다. 이번 승인은 1,458명의 어린이가 참여한 획기적인 3상 시험에서 비롯되었으며, 이는 지금까지의 집먼지 진드기 알레르겐 면역요법 중 가장 큰 소아 임상 시험입니다.
이 연구는 위약 대비 총 결합 비염 점수에서 22%의 상대적 감소를 보여주었습니다. ODACTRA는 설하 정제로 투여되며, 주사 기반 치료에 대한 편리한 대안을 제공합니다. 안전성 프로파일은 성인/청소년의 결과와 일치하며, 대부분 경증에서 중등도의 부작용이 발생했습니다. 치료와 관련된 가장 흔한 부작용으로는 구강 가려움증, 인후 자극 및 귀 가려움증이 있었으며, 소아 그룹에서는 심각한 부작용이나 아나필락시스 사례가 보고되지 않았습니다.
ALK (AKBLF) a annoncé l'approbation par la FDA d'une indication élargie pour ODACTRA® afin de traiter la rhinite allergique induite par les acariens de la poussière domestique chez les enfants âgés de 5 à 11 ans, élargissant ainsi la plage d'âge précédente de 12 à 65 ans. L'approbation découle d'un essai de Phase 3 marquant impliquant 1 458 enfants - le plus grand essai pédiatrique d'immunothérapie aux allergènes d'acariens de la poussière à ce jour.
L'étude a démontré une réduction relative de 22% du score total combiné de rhinite par rapport au placebo. ODACTRA est administré sous forme de comprimé sublingual, offrant une alternative pratique aux traitements par injection. Le profil de sécurité était en accord avec les résultats chez les adultes/les adolescents, avec principalement des événements indésirables légers à modérés. Les événements indésirables les plus courants liés au traitement comprenaient des démangeaisons buccales, une irritation de la gorge et des démangeaisons des oreilles, sans signalement d'événements indésirables graves ni de cas d'anaphylaxie dans le groupe pédiatrique.
ALK (AKBLF) hat die FDA-Zulassung für die erweiterte Indikation von ODACTRA® zur Behandlung der durch Hausstaubmilben verursachten allergischen Rhinitis bei Kindern im Alter von 5 bis 11 Jahren bekannt gegeben, was den vorherigen Altersbereich von 12 bis 65 Jahren erweitert. Die Zulassung basiert auf einer wegweisenden Phase-3-Studie, an der 1.458 Kinder teilnahmen – die größte pädiatrische Studie zur Immuntherapie mit Hausstaubmilbenallergenen bis heute.
Die Studie zeigte eine relative Reduktion von 22% im gesamten kombinierten Rhinitis-Score im Vergleich zu Placebo. ODACTRA wird als sublinguale Tablette verabreicht und bietet eine bequeme Alternative zu injektionsbasierten Behandlungen. Das Sicherheitsprofil stimmte mit den Ergebnissen bei Erwachsenen/Heranwachsenden überein, wobei die meisten unerwünschten Ereignisse mild bis moderat waren. Die häufigsten behandlungsbezogenen unerwünschten Ereignisse umfassten orale Juckreiz, Halsreizung und Ohrjuckreiz, ohne dass schwerwiegende unerwünschte Ereignisse oder Fälle von Anaphylaxie in der pädiatrischen Gruppe gemeldet wurden.
- FDA approval expands market to include children 5-11 years
- 22% efficacy rate in reducing rhinitis symptoms
- No serious adverse events in pediatric trial
- Convenient sublingual administration vs. injections
- 1.8% discontinuation rate due to adverse events
- Four patients experienced severe treatment-related adverse events
- 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 -
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.
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 ≥
In the study, children treated with ODACTRA (n=693) experienced a relative reduction in TCRS of
The full results were published in the peer-reviewed publication, The Lancet Regional Health –
Judit Nyirady, MD, MBA, SVP, Global Chief Medical Office, ALK, added: "With the expanded pediatric approval of ODACTRA in the
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.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.
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,
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 -
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.
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SOURCE ALK, INC.
FAQ
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