FDA Commitee votes to approve Sublingual Immunotherapy Treatment
Last month, the Allergenic Products Advisory Committee (APAC) of the Food and Drug Administration (FDA) met and voted that the available safety and efficacy data support approval of two sublingual allergy immunotherapy (AIT) products.
One is a grass pollen AIT tablet developed by Stallergenes and the other is Merck’s grass pollen AIT tablet. The APAC voted 9-1 regarding approval of the Stallergenes tablet and 9-0 regarding the Merck tablet. The FDA will need to give final approval, but it usually follows the advice of its advisory committees.
AAAAI President Linda Cox, MD, FAAAAI, said in an email to members:
“There are no FDA-approved forms of sublingual AIT currently available here in the United States, so these products would be the first licensed therapies of their kind. It’s worth noting that the committee felt very strongly about including language in the prescribing instructions for both products that recommended the patient has autoinjectable epinephrine in the event of a severe allergic reaction.”