WHITEHOUSE STATION, N.J. — Merck on Thursday announced that the Food and Drug Administration has approved Ragwitek (short ragweed pollen allergen extract) tablet for sublingual use (12 Amb a 1-U). Ragwitek is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis. Ragwitek is approved for use in adults ages 18 years through 65 years.
"Ragwitek provides a new sublingual approach to allergen immunotherapy for adult patients suffering from moderate to severe ragweed pollen allergies who have declined allergy shots," said David Skoner, director of the division of allergy and immunology for Allegheny Health Network and a clinical investigator in Merck's sublingual allergen immunotherapy tablet program. "While there are regional variations, ragweed season typically starts in mid-August across the United States. During the season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication. These patients often have multiple sensitivities. To help prepare for the upcoming ragweed season, I would encourage patients diagnosed with ragweed pollen allergies to make an appointment now with an allergy specialist to discuss options."
Ragwitek is not indicated for the immediate relief of allergic symptoms.
Ragwitek is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Symptoms of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing; a runny or itchy nose; stuffy or congested nose; or itchy and watery eyes, and typically intensify during the ragweed pollen season.
Ragwitek will be available in U.S. pharmacies by the end of April.