Update: Oralair approved for grass pollen allergy

The FDA has approved the first product for oral immunotherapy! 

Oralair is a tablet containing five grass allergens; Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass. It is manufactured by Stallergenes, a French pharmaceutical company. It will be marketed and sold in the United States by Greer Laboratories.

Allergy immunotherapy is the most effective treatment for environmental (and possibly food) allergies. It is all natural, containing only the allergens you are allergic to, and the only treatment that prevents disease. Immunotherapy can be given as a shot, drop or tablet.

It is no surprise that our first [glossary slug=’sublingual’]sublingual[/glossary] option is coming out of Europe. For many years, allergists in Europe have chosen the sublingual route rahter than subcutaneous (shots). There are other differences in the way allergies are treated here and abroad. Most sublingual products contain only one allergen. For example, grass pollen. However, up to 40% of patients have allergy to more than one substance. Allergists in the United States attempt to treat as many of the patient’s allergies as they can, administering a mix of several allergens in shot form. For example, grass pollen plus dust mites. Here is a more complete discussion, see this article (Allergy Tablet Approval Warrants Caution for Some).

It is not clear which method is better, one allergen or many. Probably there is no one right answer that would apply to everyone. The same is true in the debate, shots vs. drops/tablets. Shots are more effective but drops/tablets are more convenient. In the end, the approval of ORALAIR provides an additional treatment option for allergy specialists and their patients. If more patients get treatment then we all benefit.

UPDATE (2): TOO LATE FOR 2013

For best results, Oralair should be started 2 months prior to the grass pollen season. In the northeast, May and June are the months with peak grass pollen levels. If Oralair is available this May then it would be too late for 2013.

PRESS RELEASE (excerpts):

– Grass allergy is the most common seasonal allergy in the United States and most people are allergic to more than one type of grass. ORALAIR contains a mix of five grass pollens: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. The five grass pollens contained in ORALAIR represent those to which most patients in the U.S. are exposed.

– ORALAIR is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.

– ORALAIR is a tablet that dissolves under the tongue. The first dose is taken in the doctor’s office under medical supervision, and subsequent doses are administered once a day by the patient or the patient’s caregiver. ORALAIR treatment should be started four months before the expected onset of each grass pollen season and continued throughout the season. Allergy symptoms are reduced beginning with the first grass pollen season.

– ORALAIR was originally approved in Europe in 2008 and is currently authorized in 31 countries around the world, including most European countries, Canada, Australia, and Russia for the treatment of grass pollen allergy. In Canada, ORALAIR was launched in 2012, making it the first allergy immunotherapy tablet to be registered and marketed in North America. Worldwide post-marketing experience with ORALAIR includes more than 20 million doses given to more than 110,000 patients.

– ORALAIR has been approved based on results from an extensive clinical development program. ORALAIR has been studied in double-blind, placebo-controlled trials, in both Europe and the United States in over 2,500 adults and children. The results of these trials demonstrated that pre-seasonal and co-seasonal treatment reduces patients’ allergy symptoms and their need for symptom-relieving medication. In the clinical development program, the most common adverse reactions for ORALAIR (reported in >=5% of patients) were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, and oropharyngeal pain.

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