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April 16, 2014

FDA Approves Grastek... Grass Allergy Tablet by Mouth (Instead of Allergy Shots)

Today, the FDA formally approved Grastek, the second new sublingual allergy tablet to be sold in the United States that works the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Although this tablet has been available in Europe for some time, only now has sale/distribution in the United States been allowed under prescription.

Just 2 weeks ago, FDA approved Oralair which also treats grass allergies.

Grastek (aka Grazax in Europe) is a tablet made by ALK-Abello and Merck and treats patients aged 5-65 years who are allergic to only Timothy Grass. Grastek has a simple 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.

Although in next few weeks US physicians should be able to start prescribing Oralair, it really won't do much good for this year's grass allergies because in order for this tablet to be fully effective in the treatment of grass pollen allergies, treatment needs to actually begin in December but no later than January and continue through August. Grass pollen season begins in April/May, so for at least this year, it may be too late.

For both Oralair and Grastek, epipen 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.

Sources:
Merck's grass pollen allergy drug wins U.S. approval. Reuters 4.14.14
Fauquier blog
Fauquier ENT

Dr. Christopher Chang is a private practice otolaryngology, head & neck surgeon specializing in the treatment of problems related to the ear, nose, and throat. Located in Warrenton, VA about 45 minutes west of Washington DC, he also provides inhalant allergy testing/treatment, hearing tests, and dispenses hearing aids. Google+ Christopher Chang, MD Bio

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