Dec 11 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
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
Panelists also expressed concerns about the drug's use in
asthmatic patients and in pregnant women and suggested
conducting post-approval studies to test Oralair's effects on
While the FDA considers the recommendations of the advisory
committee in deciding whether to approve a drug, it is not
obligated to follow them.
Oralair was first granted marketing approval in 2008 in
Germany and is currently marketed in 16 countries.
It is an immunotherapy that works by boosting the body's
immune system and making it less sensitive to allergens.
Allergen-specific immunotherapies are ideal for patients
whose symptoms are not adequately controlled by avoiding the
allergens or by medicines, those suffering from allergy
drug-related side effects, or who wish to reduce the long-term
use of drugs.
The committee will discuss another immunotherapy for
allergy, Grastek, made by Merck & Co on Thursday.
Grastek is an experimental oral treatment for grass allergies
and is sold as Grazax in Europe by Merck's partner ALK Abello