The U.S. Food and Drug Administration (FDA) announced that they have approved Ragwitek, a sublingually administered drug for treating hay fever.
Ragwitek contains an extract from short ragweed pollen and is a pill usually consumed by putting it under the tongue. The FDA said that people being treated with Ragwitek should start three months before the onset of ragweed pollen season and continue taking it throughout the season.
"The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research.
The FDA stated that the safety and effectiveness of Ragwitek was assessed in studies conducted within the U.S. and other countries. Safety was measured in approximately 1,700 adults. The researchers noted that itching in the mouth, ears and throat were the most commonly reported reactions.
Around 760 patients were assessed to determine effectiveness. Some patients received Ragwitek; others were given a placebo. The patients reported their symptoms and additional medications needed to get through the allergy season.
During treatment, patients who received Ragwitek reported approximately a 26 percent reduction in symptoms and the need for medications compared to those who received a placebo.
Mayo Clinic states that hay fever causes cold-like symptoms such as running nose, itchy eyes, congestion, and sneezing and sinus pressure. However, it is caused due to a sensitive response to allergens, like pollen, dust mites or pet dander.
According to Philly, Ragwitek will hit shelves in pharmacies by April 30.
