The U.S. Food and Drug Administration has approved Grastek, which is intended to treat allergies to grass pollen, for use by individuals between the ages of 6 and 65. Merck says it plans to release the drug to consumers later this month. In December, Grastek was unanimously recommended by an FDA advisory panel, Reuters notes.
While the panel voted to recommend the drug’s approval, it also called for follow-up studies to assess Grastek’s safety in children. Grastek is delivered in the form of a tablet that dissolves while held under the tongue. The pill contains timothy grass allergen extracts. The panel noted reports of oral irritation and swelling linked to the drug.
The Merck drug has been available in Europe since 2006 and was cleared by Canadian regulators in February. Grastek was created under a partnership between Merck and ALK Abello.
Grastek is the second pollen allergy drug to receive approval from U.S. regulators this month.
MRK stock rose modestly in Tuesday pre-market trading. MRK shares have climbed almost 20% over the past 12 months.
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