FDA approves first sublingual allergen immunotherapy tablet for treatment of short ragweed pollen allergies

April 21, 2014

FDA approved Short Ragweed Pollen Allergen Extract (Ragwitek, Merck) the first sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults aged 18 years through 65 years.

FDA approved Short Ragweed Pollen Allergen Extract (Ragwitek, Merck) the first sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults aged 18 years through 65 years.

Ragwitek is not indicated for the immediate relief of allergic symptoms.

Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it under the tongue, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a healthcare professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home.  

“This new sublingual immunotherapy tablet offers allergy specialists an important new alternative to help treat their patients’ ragweed allergies,” said Bob Consalvo, director, global communications, Merck. “Many patients with moderate to severe ragweed allergies may be candidates for immunotherapy, but decline to take allergy shots. Ragwitek is an important new option for these patients.”

 

Prior to the FDA approval of Ragwitek, ragweed allergy immunotherapy historically involved patients receiving subcutaneous injections in the physician’s office, according to Consalvo. 

“This meant frequent visits to the doctor’s office for allergy shots,” he said.  The first dose of Ragwitek is given in the physician’s office, but if the patient tolerates the first dose, patients self-administer subsequent doses at home. This may be more convenient for many patients.”

Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short ragweed pollen is one of the most common seasonal allergens and is prevalent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots. 

The safety and effectiveness of Ragwitek was evaluated in studies conducted in the United States and internationally. Safety was assessed in approximately 1,700 adults. Itching in the mouth and ears and throat irritation were the most commonly reported adverse reactions by patients treated with Ragwitek. Of the 1,700 adults, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek; others received a placebo. The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for 1 ragweed pollen season, patients who received Ragwitek experienced approximately a 26% reduction in symptoms and the need for medications compared to those who received a placebo. 

Prescribing information for Ragwitek includes a boxed warning regarding severe allergic reactions.