The Formulary Files

Three allergy medications approved in one month

Krishna Rutvij Patel, PharmD

The FDA’s approval of three sublingual immunotherapy tablets marks the entrance of orals into the allergen immunotherapy market that is dominated by allergen extracts administered subcutaneously. Oralair and Grastek are both approved for treatment of moderate to severe allergy to grass pollen, whereas Ragwitek is approved for allergy to ragweed pollen. Patients who do not respond adequately to symptomatic treatments now have a more convenient and viable option. Despite these drugs’ convenient dosing, formulary decision makers must consider the threat to adherence that these drugs pose, as patients can now take their allergy treatment at home rather than having to visit physicians’ offices, where adherence is assured. With Oralair and Grastek having similarities in indication and in efficacy, it is important to pinpoint minute differences. Below we have a bird’s-eye view of the three allergy medications, which were approved in April.

(approved April 1)
(approved April 14)
(approved April 17)
Sublingual tablet
Dosing frequency Once daily Once daily Once daily
Indicated for allergy to grass pollen
Indicated for allergy to ragweed pollen
Number of pollen extracts within tablet 5 1 1
Approved age group ≥10 years ≥5 years ≥18 years
Months prior to pollen season when therapy should be initiated 4 3 3
Sources: Prescribing information documents for Grastek and Ragwitek; news release regarding Oralair approval

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