Dec 12 A panel of experts advising the U.S. Food
and Drug Administration said an oral drug made by Merck & Co
was effective in treating grass pollen allergy but
expressed concerns about the drug's safety in children.
The advisory panel voted 9-0 that available data supported
the efficacy of the immunotherapy drug, Grastek, in treating
Timothy grass pollen allergy in patients 5 years or older.
The committee also voted unanimously in favor of the drug's
safety, on the condition that patients taking the drug have easy
access to epinephrine - a medicine used to treat serious
allergic reaction such as ones that can result from the use of
Panelists recommended post-approval studies of the drug to
test its safety in children aged 5 to 11 years, citing side
effects such as lip swelling, throat irritation and tightness
and oral blistering.
Grastek is an immunotherapy drug which contains extracts of
Timothy grass allergen. Immunotherapies work by boosting the
body's immune system and making it less sensitive to allergens.
The tablet, meant to be placed under the tongue, helps the
body to adjust to the allergen. It is sold as Grazax in Europe
by Merck's partner ALK Abello.
The FDA usually takes the recommendations into account while
making a decision on approving a drug, but it is not obligated
to follow them.
On Wednesday, the committee backed another allergy
immunotherapy made by France's Stallergenes SA.
Stallergenes' Oralair is also to be placed under the tongue
and comprises extracts from five grass pollens - Kentucky
bluegrass, Orchard, Perennial rye, Sweet vernal and Timothy.
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.