FDA Approves First Sublingual Immunotherapy Product

As announced to AAAAI members last week, the Food and Drug Administration (FDA) has approved the first sublingual allergy immunotherapy product for the U.S. market.

A prominent USA Today story detailing the news quoted AAAAI President James T. Li, MD, PhD, FAAAAI, and Immediate Past-President Linda Cox, MD, FAAAAI, was quoted in a story from Internal Medicine News.

The sublingual immunotherapy product the FDA approved is for the treatment of grass pollen allergy and will be marketed as ORALAIR®. There are several points AAAAI members should also know:

• It is a sublingual tablet with a mix of five grass allergen extracts and is approved for use in patients ages 10 through 65.
• The grasses included are Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass.
• It is indicated for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or serum-specific IgE antibodies to any of the five grass species contained in the product.
• According to an announcement from the FDA, the prescribing information has a boxed warning that severe allergic reactions can occur.

“Gaining the first FDA-approved sublingual immunotherapy product is a significant moment for our specialty and will certainly raise the profile of allergy immunotherapy as a treatment option,” said Dr. Li in an email communication to members regarding the FDA decision.

The AAAAI anticipates that the FDA will soon announce final approval of two other sublingual tablets that its Allergenic Products Advisory Committee voted to approve.