U.S. FDA panel says Oralair profile supports approval -documents
Dec 9 (Reuters) - An oral immunotherapy aimed at grass and pollen allergies has a benefit and safety profile that supports its approval, according to briefing documents posted on Monday by the U.S. Food and Drug Administration ahead of a meeting by outside experts to discuss the drug.
Oralair, made by France's Stallergenes SA, would be the first such licensed therapy in the United States. It has been in use in Europe for several years.
The documents were posted prior to a meeting on Wednesday of an FDA advisory committee meeting that will provide a recommendation on whether the drug merits U.S. approval. The FDA considers advisory panel views when it decides whether to approve a drug, but is not obligated to follow its recommendation.
The FDA committee documents said that several large studies in Europe and the United States showed that the drug's efficacy was "robust" and "consistent." The documents said the treatment was "generally well-tolerated."
On Thursday, the committee will meet to discuss Grastek, an oral treatment for grass allergies that would be sold by Merck & Co. In Europe, Merck's partner, Danish company ALK Abello, sells the product as Grazax.
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