Dec 9 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
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.