Health Canada Approves ALK's RAGWITEK® Sublingual Allergy Immunotherapy (SLIT)-Tablets for Pediatric Patients with Ragweed Allergy

- With the indication expanded to pediatric patients, ALK Canada now provides adults and children a SLIT-tablet option to treat allergies to ragweed pollen, one of the most common allergens found in the provinces of Ontario and Quebec -

MISSISSAUGA, ON, Dec. 22, 2020 /CNW/ -- Today ALK, a global, research-driven pharmaceutical company, announced that Health Canada has approved once-daily RAGWITEK® (Standardized Allergen Extract, Short Ragweed (Ambrosia artemisiifolia) Sublingual Tablet) for the treatment of moderate to severe ragweed pollen allergies in children age five and older. RAGWITEK had received Health Canada approval for adult use in 2014.

RAGWITEK is indicated for reducing the symptoms of moderate to severe seasonal short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults and children five years of age or older confirmed by clinically relevant symptoms for at least one pollen season (age six or younger) or two pollen seasons (age seven or older) and a positive skin prick test and/or a positive titre to Ambrosia artemisiifolia specific IgE, and who have responded inadequately, or are intolerant to conventional pharmacotherapy. Treatment with RAGWITEK should only be prescribed and initiated by physicians with adequate training and experience in the treatment of respiratory allergic diseases.

"Ragweed pollen is a common cause of seasonal airborne allergy in North America, causing allergic rhinitis and conjunctivitis," said Anne Ellis, M.D., Clinical Allergist and Immunologist, Professor of Medicine, Queen's University Department of Medicine. "Allergic rhinitis affects millions of adults and children¹ and many patients may not get complete relief from symptoms such as runny nose, congestion, itching around the nose and eyes, and sneezing with currently available treatment options. Sublingual immunotherapy targets the specific allergy trigger and underlying cause of the allergy using a person's own immune system, helping patients achieve long-lasting symptom relief with an option that can be taken at home following an initial visit with an allergist." 

The approval was based, in part, on data from the largest phase III randomized, multicenter clinical trial in children with ragweed allergic rhinitis and conjunctivitis conducted to date. The randomized, double-blind, parallel group, multicenter clinical trial that evaluated the efficacy and safety of RAGWITEK in 1,022 children and adolescents ages 5-17 years with a history of ragweed-induced rhinoconjunctivitis and sensitivity to short ragweed over an approximately 20-28 weeks treatment duration.

Treatment with RAGWITEK significantly improved symptoms in children age 5-17 and decreased medication use compared to placebo. 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 pediatric approval of RAGWITEK in Canada, we can now offer a treatment option for pediatric and adult patients 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 committed to bringing innovative solutions to the millions of people who suffer from chronic allergies. The approval of RAGWITEK for children in Canada builds 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. SLIT-Tablets are prescription medication taken daily that offers flexible daily dosing. Subcutaneous immunotherapy (SCIT), also known as allergy shots, is another form of allergy immunotherapy administered in a doctor's office.

About ALK
ALK is a global specialty pharmaceutical company focused on the prevention, diagnosis and treatment of allergies. In Canada, it markets allergy immunotherapy treatments, including four once-daily sublingual allergy immunotherapy (SLIT)-tablets, and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,400 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

For further information, please contact:

ALK:
Investor Relations: Per Plotnikof, tel. [phone], mobile [phone]
Media: Stuart Loesch, tel. [phone], mobile [phone]

¹ Chan-Yeung M, Anthonisen NR, Becklake MR, et al. Geographical variations in the prevalence of atopic sensitization in six study sites across Canada. Allergy. 2010;65(11):1404-1413. doi:10.1111/j.1398-9995.2010.02399.x
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.

SOURCE ALK, INC.

Related Links

http://www.alk.net