The U.S. Food and Drug Administration (FDA) has finally given its go signal for a drug that could replace allergy-desensitizing shots in some individuals.
The agency said on Wednesday that is has already green-lighted Oralair to become the first drug in the U.S. for reducing hay fever symptoms. Hay fever, which affects about 30 million Americans, is a type of allergy caused by pollen, dander, insect venom and other allergens that trigger the mucous membranes of the nose and eyes to get itchy and inflamed.
Patients can get allergy shots to reduce their sensitivity but some opt for antihistamines that merely treat the symptoms such as sneezing, watery eyes and runny nose.
"While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen," said Karen Midthun, director of FDA's Center for Biologics Evaluation and Research. "The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider's office. Oralair can be taken at home after the first administration."
Oralair was developed by French company Stallergenes and will be the first so-called sublingual grass allergy tablet that got approved for use in the U.S. The tablet, which dissolves in the tongue, is for use by patients between 10 to 65-years old and needs to be used taken once daily. Stallergenes has not yet released the price of the tablet but said that it will be available in May this year.
Oralair may be promising but it appears that it may not yet completely replace allergy shots. Based on studies, it can only reduce symptoms by 16 to 30 percent, which as per James Li, chairman of the division of allergy and immunology at Mayo Clinic in Rochester, Minnesota, is not as good as allergy shots in studies albeit the two treatments have yet to be thoroughly compared.
Stallergenes' hay fever drug also treats only allergy caused by certain grass pollens which include Perennial Rye, Timothy, Sweet Vernal, Orchard and Kentucky Blue Grass.
Stanley Fineman, former president of the American College of Allergy, Asthma and Immunology said that this limitation is one drawback of the Oralair. Nonetheless, he noted that the tablet can offer a new option for some patients.