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FDA Panel: Allergy Treatment Ragwitek Is Safe and Effective

Sublingual pill offers alternative to injections (January 24)

In a briefing document posted online, the FDA’s Allergenic Products Advisory Committee has reported that Ragwitek (MK-3641, Merck, Sharp & Dohm), a sublingual pharmaceutical formulation of the allergen extract from short ragweed pollen (Ambrosia artemisiifolia), is a well-tolerated and effective immunotherapy option for patients with ragweed pollen-induced allergic rhinitis.

The treatment offers an alternative for adult patients (aged 18 years and older) in whom existing subcutaneous immunotherapy is appropriate, but impractical or not preferable. Treatment is initiated at least 12 weeks before the ragweed pollen season and is continued throughout the season.

In contrast to injection-based immunotherapy, the sublingual ragweed tablet does not require up-titration to achieve the maintenance dosing. Immunologic data indicate that the tablet acts through the lingual/oral immune system by modulating the allergen-specific immune response in ragweed allergic patients.

“Based on indirect comparisons, the efficacy demonstrated by MK-3641 is generally similar to or better than first-line allergic rhinoconjunctivitis pharmacotherapy. The adverse events were usually of mild intensity and short-lived,” the panel reported.

Their opinion was posted a few days ahead of a meeting scheduled for January 28, during which the committee will discuss whether Ragwitek merits marketing approval.

Sources: FDA; January 24, 2014; and Reuters; January 24, 2014.

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