Hay Fever Drug Oralair Gets FDA’s approval

The U.S. Food and Drug Administration (FDA) approved Oralair pills for patients suffering from hay fever or Allergic Rhinitis, with or without eye inflammations.

Hay fever is a pollen-induced allergy affecting nearly 30 million people in the U.S. and more than 500 million people worldwide. Oralair, a sublingual drug manufactured by the French pharmaceutical company Stallergenes, replaces allergy shots and can be orally ingested by placing the pill under the tongue. It contains allergen extracts and pollen specific IgE antibodies from various grass species like Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.  Tests revealed that the drug can be safely used to treat people between the ages 10 and 65.      

Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research said in the agency press release, "While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen."

Various trials across the United States and Europe confirmed the drug's efficacy on nearly 2500 people. Some of these participants received Oralair while the rest were given a placebo. Experts used self reported data of a patient's need for alternative medicines and symptoms for hay fever that includes frequent sneezing, nasal irritation, watery eyes, runny nose and nasal congestion throughout the allergy season.

It was observed that allergy symptoms significantly reduced among 16 to 30 percent of the participants who received Oralair when compared to those in the control group.

Christian Chavy, newly appointed Chief Executive Officer of Stallergenes said in the company's press release, "We are very pleased with the U.S. approval of Oralair as it will bring a true benefit to US patients suffering from grass pollen-induced allergy. The company not only developed Oralair but it also continues to expand the frontiers of allergen immunotherapy."

The agency recommends patients to start the treatment as early as four months before and throughout the allergy season. The initial dose of Oralair must be received in clinics under a doctors' supervision to note the possibility for side-effects and adverse reactions like swelling of mouth, eyes and tongue and throat irritation. Later, it can be prescribed to patients who can take the dry once daily on their own.

Oralair is available in 31 countries across the world and is mostly sold in Canada, Australia and Russia to treat grass pollen allergy. The company estimates more than 20 million doses of Oralair are given to 110,000 patients worldwide.

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