TRENTON, N.J. – The Food and Drug Administration said Wednesday that it has approved the first tablet in the U.S. for gradually reducing hay fever symptoms, an alternative to months of weekly doctor visits for uncomfortable allergy-desensitizing shots.
Oralair was approved for patients ages 10 through 65. It's made by France's Stallergenes SA, a leader in immunotherapy medicines that dissolve under the tongue.
Oralair tablets are to be taken daily starting four months before grass pollen season to reduce allergic reactions to the five most common U.S. grass types: Kentucky bluegrass, orchard, perennial rye, sweet vernal and Timothy. It contains freeze-dried extracts from pollens of those grasses.
Meanwhile, drugmaker Merck & Co. of Whitehouse Station, N.J., expects an FDA ruling by midyear on its two experimental immunotherapy tablets, one for ragweed and one for grass pollen allergies. Merck is a leader in respiratory treatments, selling Claritin allergy pills and Nasonex allergy spray, multiple asthma inhalers and Singulair, a former $5 billion-a-year allergy and asthma pill now available as an inexpensive generic.
About 60 million Americans have hay fever, but fewer than 3 million are treated with allergy shots. Until now, their only other option was medicines to temporarily relieve sneezing, runny nose, congestion, watery eyes and itchy eyes and nose.
In patient testing over one grass pollen season, Oralair reduced symptoms and need for medication by 16 percent to 30 percent, versus dummy tablets.
Common side effects include throat irritation and mouth swelling. Severe allergic reactions, including life-threatening ones, are possible. For that reason, the first dose is given at a doctor's office, where the patient is watched for potential problems.
Oralair was approved in Europe in 2008 and is approved for sale in 31 countries, including Canada, Australia and Russia.