Two New Sublingual Allergy Tablets Approved by FDA Advisory Committee

This week, the FDA Allergenic Products Advisory Committee unanimously supported approval for two new sublingual allergy tablets (Oralair and Grastek) that work the same way injection immunotherapy aka allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Although both tablets have been available in Europe for some time, final "official" FDA approval may not occur until end of 2014 (or later) for sale/distribution under prescription in the United States.

Oralair is made by a French pharmaceutical company Stallergenes and treats patients aged 10-65 years who are allergic to 5 different grasses: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Treatment is composed of a buildup and maintenance phase. Starting 4 months prior to the grass pollen season, a 100 IR tablet is administered under the tongue in a medical office to ensure no significant side effects. At home on day 2, two 100 IR tablets are administered. On day three and daily thereafter, a 300 IR tablet is placed under the tongue until the end of the grass pollen season. The tablets take about 1 minute to dissolve.

Grastek (aka Grazax in Europe) is made by ALK-Abello and Merck and treats patients aged 5-65 years who are allergic to only Timothy Grass. Grastek has a simpler regimen of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the grass pollen season. As with Oralair, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

For both tablets, an epinephrine pen injector needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Members of the Allergen Product Advisory Committee also pointed out the limitation of single grass family therapy, noting that patients in southern United States who are allergic to Bermuda or Bahia grasses would not benefit from these products.

Sources:  Members of the Allergen Product Advisory Committee also pointed out the limitation of single grass family therapy, noting that patients in southern United States who are allergic to Bermuda or Bahia grasses would not benefit from these products.

Sources:  APAC Podcast, Medscape 12/12/13

Comments:




Archive:

Tags