FDA Committee Votes to Approve Ragweed SLIT Option

In late January, the Allergenic Products Advisory Committee (APAC) of the Food and Drug Administration (FDA) met and voted that the available safety and efficacy data supports the approval of another sublingual allergy immunotherapy (AIT) product. The product is a ragweed allergy tablet from Merck.

This is the third SLIT option the committee has voted to approve in recent months. Back in December 2013, the APAC met and voted to approve two grass pollen AIT tablets. One is developed by Stallergenes and the other by Merck.

AAAAI President Linda Cox, MD, FAAAAI, discussed the committee’s votes on the grass pollen tablets in last month’s President’s Message.

Dr. Cox is also the author of an article titled “Sublingual immunotherapy for aeroallergens: Status in the United States,” which appears in the January issue of Allergy and Asthma Proceedings. The article is open-access and available here.

The FDA will need to give final approval of the three SLIT products, but it usually follows the advice of its advisory committees.