U.S. FDA Approves ALK's ODACTRA® (House Dust Mite Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Adolescents

? ODACTRA is now indicated to treat house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, in persons 12 through 17 years of age, in addition to adults 18 through 65 years of age ?

? Nearly 50% of patients with allergies are sensitive to HDMs¹ ?

ROUND ROCK, Texas, Jan. 25, 2023 /PRNewswire/ -- ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration (FDA) approved ODACTRA^® (House Dust Mite Allergen Extract) Tablet for Sublingual Use for the treatment of house dust mite (HDM)-induced allergic rhinitis in persons ages 12 through 17. ODACTRA was first launched for adults, ages 18 through 65, in the U.S. in 2017, and the expanded indication builds on ALK's treatment offerings for those suffering from allergies.

ODACTRA is an allergen extract indicated as immunotherapy for HDM-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus HDMs, or skin testing to licensed HDM allergen extracts. ODACTRA is approved for use in persons 12 through 65 years of age. ODACTRA is not indicated for the immediate relief of allergic symptoms.² Please see Important Safety Information, including Boxed Warning, below.

"In many cases, for adolescents experiencing allergy symptoms throughout the year, house dust mites may be the underlying allergy trigger," said Michael Blaiss, MD, clinical professor of pediatrics, division of allergy/immunology at the Medical College of Georgia at Augusta University. "Allergies interfere with a critical time of adolescent development when they undergo physical, cognitive, emotional and social changes. ODACTRA sublingual immunotherapy treats house dust mite allergy and can even help those polysensitized patients manage their symptoms."

Data from several studies served as the basis for the expanded indication. The 28-day MT-18 trial was the first Phase 3 sublingual immunotherapy (SLIT)-tablet trial conducted only in adolescents. It evaluated the safety of ODACTRA in European adolescents aged 12 to 17 years (N=253) with HDM allergic rhinitis with/without conjunctivitis (AR/C), with or without mild asthma. The MT-18 trial's primary endpoint of at least one treatment-emergent adverse event (TEAE) was reported in 223 (88%) subjects and confirmed data from previously conducted North American and Japanese trials indicating that the HDM SLIT-tablet was well tolerated in adolescents with HDM AR/C.³

A post hoc analysis of two pooled, double-blind, placebo-controlled trials conducted in North America and Japan, adolescents aged 12 to 17 years (N=395) with HDM allergic rhinitis were randomized to up to one year of treatment.⁴ The study found that ODACTRA reduced the average total combined rhinitis score (TCRS), the study's primary endpoint, by 22% compared to placebo (treatment difference of ?1.04; P<.01).⁴

The safety profile in children and adolescents was consistent with the safety profile in adults, and no treatment-related anaphylaxis, epinephrine administrations, severe local swellings, severe mouth or throat edema, or eosinophilic esophagitis occurred in the trials.³ The most common treatment-related adverse events (TRAEs) were local application site reactions.³ Most TRAEs were mild in intensity and were typically experienced the first one to two days of treatment.³

"We are proud to now offer ODACTRA, a convenient allergy immunotherapy tablet that can be taken at home following an initial administration visit with a healthcare provider experienced in diagnosing and treating allergies, to adolescents in the United States. ODACTRA is a flexible solution that offers the opportunity for relief as teens and parents navigate their overscheduled lives," said Hans Lindeberg, senior vice president of ALK North America. "This milestone underscores our commitment to continue to bring innovative solutions to the millions of people who suffer from chronic allergies, especially to adolescents during their critical development years."

ODACTRA is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat house dust mite allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. ODACTRA may be prescribed for persons 12 through 65 years of age who are allergic to house dust mites. ODACTRA is NOT a medication that gives immediate relief for symptoms of house dust mite allergy.²

• 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 should prescribe auto-injectable epinephrine, a medicine you can inject if you or your child have a severe allergic reaction after taking ODACTRA. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.
• If you forget to take ODACTRA, do not take two tablets. Take the next tablet at your normal scheduled time the next day. If you miss more than one tablet of ODACTRA, contact your doctor before restarting.
• Do not take ODACTRA if:
• You have severe, unstable or uncontrolled asthma
• You had a severe allergic reaction in the past that included any of these symptoms: trouble breathing, dizziness or fainting, rapid or weak heartbeat
• You have ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before
• You have ever been diagnosed with eosinophilic esophagitis
• You are 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 have asthma, depending on how severe it is
• You suffer from lung disease such as chronic obstructive pulmonary disease (COPD)
• You suffer from heart disease such as coronary artery disease, an irregular heart rhythm, or you have hypertension that is not well controlled
• You are pregnant, plan to become pregnant during the time you will be taking ODACTRA, or are breast-feeding
• You are unable or unwilling to administer auto-injectable epinephrine to treat a severe allergic reaction to ODACTRA
• You are 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)
• If you are 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 have any mouth surgery procedures (such as tooth removal), develop any mouth infections, ulcers or cuts in the mouth or throat, or have heartburn, difficulty swallowing, pain with swallowing, chest pain that does not go away or worsens, asthma or any other breathing condition that worsens, 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, 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.

ALK is a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,600 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

For further information, please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Dan Commerford, tel. +1 908 842 8355

¹ Bauchau V. Prevalence and rate of diagnosis of allergic rhinitis in Europe. European Respiratory Journal. 2004;(5):758-764. doi:10.1183/09031936.04.00013904.
² ODACTRA. Prescribing information. ALK-Abelló, Inc.; Rev. 2023.
³ Horn A, Bernstein DI, Okubo K, et al. Safety of house dust mite sublingual immunotherapy tablet in adolescents with allergic rhinoconjunctivitis: clinical trial results. JACI. 2022.
⁴ Matsuoka T, Bernstein DI, Masuyama K, et al. Pooled efficacy and safety data for house dust mite sublingual immunotherapy tablets in adolescents. Pediatr Allergy Immunol. 2017;28(7):661-667. doi:10.1111/pai.12747.

SOURCE ALK, INC.