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Gain insight into allergy and allergen immunotherapy at Allergy School. FDA Committee votes to approve SLIT treatments.
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SLIT: dealing with trouble, doing it right. Allergy SchoolAn Insight into Allergy and Allergen Immunotherapy11 – 13 September 2014Athens, Greece Giovanni B Pajno MD Professor of Pediatrics Department of Pediatrics – Allergy Unit University of Messina Italy
FDA Committee Votes to Approve SLIT Treatments 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." Dr. Cox also discusses the news in this month's President's Message. More information, including a webcast of the meetings, is available from the FDA website
SLIT 1. Early intervention 2. Long lasting effect 3. Adherence
SLIT 1. Early intervention 2. Long lasting effect 3. Adherence
G.B. Pajno Persistent Allergic Diseases Persistent Wheeze Atopic Dermatitis Hay Fever Food Allergy TH2 polarized Immunity Food Allergens Inhalant Allergens Allergens Exposure SLIT Birth Increasing post-natal age Hampering the progression and worsening of IgE mediated disorders J Allergy Clin Immunol 2007;119:796-801.
Specific immunotherapy: beyond the clinical scores Passalacqua G Annals of Allergy 2011;107:401-406 Figure 1. Percentage of children in the immunotherapy and control groups who developed asthma after 3 years, in the 3 available trials. In the study by Marogna et al,37 the development of persistent asthma was assessed
SLIT 1. Early intervention 2. Long lasting effect 3. Adherence
SLIT 1. Early intervention 2. Long lasting effect 3. Adherence
Discontinuation 52% three y. old 18% four y. " 13% five y. "
Exp Review Clin Immunol in press Pajno G et al.