Ragwitek was approved yesterday by the U.S. Food and Drug Administration (FDA) as a treatment for short ragweed pollen induced allergic rhinitis, also known as hay fever. The approval offers an alternative to allergy shots for millions of adults trying to manage their ragweed pollen allergies, says Karen Midthun, MD, who is director of the FDA Center for Biologics Evaluation and Research.
The first sublingual (under the tongue) allergen extract for treating allergic rhinitis, the new medication contains short ragweed pollen extract. One tablet is placed under tongue once a day starting 12 weeks before ragweed pollen season starts and continuing through the season. The tablet dissolves in about 10 seconds. The first dose is taken at the doctor’s office, to watch for any adverse reactions. After that patients can take the medication at home.
Ragwitek is approved for hay fever with or without eye inflammation (conjunctivitis) in adults 18 through 65 years old. Safety studies did not include any patients over 51, so the FDA advisory panel felt the safety evidence was not sufficient for older patients. They did not seek approval for pediatric use.
Between 10 to 25 percent of the U.S. population is affected by allergic rhinitis. Short ragweed pollen is one of the most common seasonal allergens causing symptoms. Allergic rhinitis sufferers, with or without conjunctivitis, may experience repetitive sneezing, runny nose, nasal congestion and itching, and watery, itchy eyes.
Short ragweed pollen is widespread during the late summer and early fall in most of the U.S. Sufferers previously managed their allergy through shots, taking medications to relieve the symptoms, or avoiding the allergen. Allergy shots have been effective treating allergic rhinitis, but experts do not know how long they might continue to work after regular doses are discontinued. Some people have their allergies return when the shots are stopped.
Safety studies on Ragwitek were done both in the U.S. and internationally, which included 1,700 adults, some of whom received a placebo and some who received the actual medication. Patients reported on their hay fever symptoms and any additional medication they needed for controlling those symptoms during the allergy season.
The study results found that the patients who got Ragwitek had about a 26 percent reduction in symptoms and their corresponding need for medication over one ragweed pollen season.
The new ragweed allergy medication is the third sublingual immunotherapy (SLIT) approved this month. The others were Merck’s Grastek allergy tablet for Timothy grass pollen, and Greer’s immunotherapy Oralair tablet for multi-grass pollen.
No SLIT agents had been approved prior to this month, although off-label under-the-tongue drops made from allergy shot extracts have been used widely.
The most common adverse reactions to Ragwitek were throat irritation, and itching in ears and mouth. The box warns of the risk of severe allergic reactions, and recommends that patients be prescribed auto-injectable epinephrine in case of problems.
The new sublingual tablet is manufactured for Merck, Sharp & Dohme Corp. by Catalent Pharma Solutions Limited, in the United Kingdom. Ragwitek is a new alternative to treatment by allergy shots that are required one to four times per week.
By Beth A. Balen