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U.S. FDA Approves ALK's RAGWITEK® (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Chi

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

- RAGWITEK is now indicated to treat ragweed pollen allergy in children and adolescents five through 17 years of age, in addition to adults through 65 years of age -

- Ragweed pollen is one of the most common allergens found in North America and affects approximately 23 million people in the U.S.1 -

PR Newswire

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 patientT 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





RAGWITEK can cause systemic allergic reactions including anaphylaxis which may be life-threatening and severe local reactions, including laryngopharyngeal swelling, which can compromise breathing and be life-threatening. Educate patients (or their parents/guardians) to recognize the signs and symptoms of these allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. Allergic reactions may require treatment with epinephrine.





Prescribe auto-injectable epinephrine to patients receiving RAGWITEK. Instruct patients (or their parents/guardians) to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency auto-injectable epinephrine. Instruct patients (or their parents/guardians) to seek immediate medical care upon use of auto-injectable epinephrine and to stop treatment with RAGWITEK. Review the epinephrine package insert for complete information.





Administer the initial dose of RAGWITEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases and prepared to manage a life-threatening systemic or local allergic reaction. Observe patients in the office for at least 30 minutes following the initial dose of RAGWITEK.





Patients who have persistent and escalating adverse reactions in the mouth or throat should be considered for discontinuation of RAGWITEK. Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy. Discontinue RAGWITEK and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.





RAGWITEK has not been studied in subjects with severe asthma. Immunotherapy with RAGWITEK should be withheld if the patient is experiencing an acute asthma exacerbation.





RAGWITEK has not been studied in subjects who are receiving concomitant allergen immunotherapy. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.





Stop treatment with RAGWITEK to allow complete healing of the oral cavity in patients with oral inflammation (e.g., oral lichen planus, mouth ulcers or thrush) or oral wounds, such as those following oral surgery or dental extraction.





The most common adverse reactions reported in adults treated with RAGWITEK vs placebo included throat irritation (16.6% vs 3.3%), oral pruritus (10.9% vs 2.0%), ear pruritus (10.4% vs 1.1%), oral paraesthesia (10.0% vs 4.0%), mouth edema (6.1% vs 0.5%), and tongue pruritus (5.1% vs 0.5%).





The most common solicited adverse reactions reported in children and adolescents 5 through 17 years of age treated with RAGWITEK vs placebo included throat irritation/tickle (48.3% vs 17.7%), itching in the mouth (47.8% vs 11.2%), itching in the ear (33.9% vs 6.3%), mouth pain (18.9% vs 4.5%), swelling of the lips (13.8% vs 1.2%), nausea (11.5% vs 3.3%), swelling of the tongue (11.3% vs 0.8%), throat swelling (10.7% vs 1.6%), and stomach pain (10.1% vs 4.5%).





The most common unsolicited adverse reactions reported in children and adolescents 5 through 17 years of age treated with RAGWITEK vs placebo included oral pruritus (7.8% vs 1.0%), throat irritation (7.6% vs 1.6%), ear pruritus (4.5% vs 0.2%), and tongue pruritus (4.5% vs 0.4%).





Because systemic and local adverse reactions with immunotherapy may be poorly tolerated during pregnancy, RAGWITEK should be used during pregnancy only if clearly needed.



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.

For further information, please contact:

ALK:

Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525

Media: Stuart Loesch, tel. +1 908 842 8363, mobile +1 267 753 5838

_____________________

1 Ragweed Allergy. American College of Allergy, Asthma & Immunology. https://acaai.org/allergies/types/ragweed-allergy. Accessed March 22, 2021.

2 Nolte H, Bernstein DI, Nelson HS, Ellis AK, Kleine-Tebbe J, Lu S. Efficacy and safety of ragweed slit-tablet in children with allergic rhinoconjunctivitis in a randomized, placebo-controlled trial. J. Allergy Clin. Immunol Pract. 2020;8:2322–2331.e5. doi: 10.1016/j.jaip.2020.03.041.

3 Mayo Clinic. Allergy medications: Know your options. Available at: https://www.mayoclinic.org/diseases-conditions/allergies/in-depth/allergy-medications/art-20047403. Accessed March 22, 2021.

4 Gunawardana NC and Durham SR. New approaches to allergen immunotherapy. Ann Allergy Asthma Immunol. 2018;121(3):293-305.

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/us-fda-approves-alks-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-301270945.html

SOURCE ALK, INC.



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