U.S. FDA Approves ALK’s Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis

ROUND ROCK, Texas, April 19, 2021 /PRNewswire/ — ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration (FDA) approved Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the treatment of short ragweed pollen-induced allergic rhinitis in persons ages five through 65. Ragwitek was first launched for adult use in the U.S. and Canada in 2014 and was approved in nine European countries and Russia in late 2017.

Ragwitek is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Ragwitek is approved for use in persons five through 65 years of age. Ragwitek is not indicated for the immediate relief of allergic symptoms.

“Ragwitek tablets provide a new sublingual, or under-the-tongue, allergy immunotherapy treatment option for children and adolescents with seasonal ragweed allergies which often causes uncomfortable nasal symptoms and red, itchy eyes during the late summer and early fall,” said David I. Bernstein, FAAAAI, FACAAI, FACP, MD, University of Cincinnati College of Medicine, Bernstein Clinical Research. “Sublingual immunotherapy targets the specific allergy trigger, in this case ragweed pollen, and reduces ragweed allergy symptoms by stimulating the immune system, helping patients achieve symptom relief through the ragweed season with an option that can be taken at home following an initial visit with an allergist.” 

Ragweed pollen is a common cause of seasonal airborne allergy in North America, causing allergic rhinitis and conjunctivitis. While regional variation exists, in many areas of the U.S., ragweed pollen season occurs from August to November and peaks in mid-September.1

The approval was based, in part, on data from the largest Phase 3 clinical trial in children with ragweed allergic rhinitis, with or without conjunctivitis, conducted to date. The randomized, double-blind, parallel group, multicenter clinical trial evaluated the efficacy and safety of Ragwitek in 1,022 children and adolescents ages five through 17 with a history of ragweed-induced rhinoconjunctivitis and sensitivity to short ragweed over an approximately 20-28 week treatment duration.

Treatment with Ragwitek significantly improved symptoms in children and adolescents ages five through 17 and decreased symptom-relieving medication use compared to placebo. The safety profile in children and adolescents was consistent with the safety profile in adults, and overall, treatment was well tolerated and discontinuation rates due to adverse events were low.

The full results were published in the peer-reviewed publication, The Journal of Allergy and Clinical Immunology.2

“With the expanded approval of Ragwitek in the U.S., we can now offer a treatment option for children, adolescent and adult patients across North America with seasonal ragweed pollen allergies and allergic rhinitis who continue to be burdened by symptoms despite available treatments,” said Jorge Alderete, President, ALK, Inc. “At ALK, we are proud to provide innovative solutions, including Ragwitek, to the millions of people who suffer from chronic allergies and build on our SLIT-tablet portfolio of treatments for patients.”

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 taken once-daily at home after the first dose is taken at the doctor’s office.3,4 

IMPORTANT SAFETY INFORMATION ABOUT RAGWITEK

WARNING: SEVERE ALLERGIC REACTIONS

  • Ragwitek can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.
  • Do not administer Ragwitek to patients with severe, unstable or uncontrolled asthma.
  • Observe patient in the office for at least 30 minutes following the initial dose.
  • Prescribe auto-injectable epinephrine, instruct and train patients (or their parents/guardians) on its appropriate use, and instruct patients (or their parents/guardians) to seek immediate medical care upon its use.
  • Ragwitek may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
  • Ragwitek may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
  • Ragwitek is contraindicated in patients with:
    • Severe, unstable or uncontrolled asthma
    • A history of any severe systemic allergic reaction
    • A history of any severe local reaction after taking any sublingual allergen immunotherapy
    • A history of eosinophilic esophagitis
    • Hypersensitivity to any of the inactive ingredients [gelatin, mannitol and sodium hydroxide] contained in this product

    Before prescribing Ragwitek, please read the Boxed WARNING, full Prescribing Information, and Medication Guide, for additional Important Safety Information.

    About ALK

    ALK is a global allergy solutions company, with a wide range of allergy treatments, products and services that meet the unique needs of allergy sufferers, their families and doctors. Headquartered in Hørsholm, Denmark, the company employs around 2,500 people worldwide and is listed on Nasdaq Copenhagen. To learn more about ALK and allergies, visit www.alk.net.

    SOURCE ALK, INC.

    Posted: April 2021

    Related Articles:

    • FDA Approves Ragwitek for Short Ragweed Pollen Allergies – April 17, 2014
    • Merck Statement on FDA Advisory Committee Meeting for Ragwitek™ (Short Ragweed Pollen Allergen Extract), an Investigational Sublingual Allergy Immunotherapy Tablet – January 28, 2014

    Ragwitek (ragweed pollen allergen extract) FDA Approval History

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