US FDA panel backs allergy drug of France’s Stallergenes
(Reuters) – An oral immunotherapy drug for treating grass pollen allergies was backed by an independent advisory panel to the U.S. Food and Drug Administration on Wednesday. The drug, Oralair, made by France’s Stallergenes SA, is a tablet to be placed under the tongue and comprises extracts from five grass pollens mixed together – Kentucky bluegrass, Orchard, Perennial rye, Sweet vernal and Timothy. The advisory panel voted 9-1 that available data supported the drug’s efficacy in treating the allergy in patients five years of age or older. While the panel voted unanimously in favor of the drug’s safety in patients of 10 years to 65 years of age, it was divided about using the medicine in children, citing side effects.