Ragwitek Approval Expanded to Include Pediatric Use

April 19, 2021 – The U.S. FDA has approved an expanded indication for Ragwitek® (short ragweed pollen allergen extract) sublingual tablets to treat short ragweed pollen-induced allergic rhinitis in individuals who are 5-65 years old. The drug was previously approved only for use in adults.

Short ragweed pollen-induced allergic rhinitis, or hay fever, is a seasonal allergy caused by Ambrosia artemisiifolia, also known as common ragweed. The plant is native to the United States and typically blooms from July through October, producing large amounts of pollen that stay airborne and trigger allergic responses in susceptible individuals. Symptoms of allergic rhinitis – which is driven by the immune system overreacting to a substance – can include nasal congestion, coughing, sore throat, fatigue, headache, and itchy nose, eyes, throat, and skin. Ragwitek is an immunotherapy that works by exposing individuals to a small amount of ragweed pollen in a controlled fashion, training the immune system to have a less vigorous response to the allergen.

In a clinical trial, patients 5-17 years old had significantly improved symptoms on Ragwitek compared to placebo. Their use of symptom-relieving medication also decreased. Overall, the treatment was well tolerated, and Ragwitek’s safety profile in this age group was consistent with that seen in adults.

Recommended dosing is one tablet daily, with the tablet placed immediately under the tongue and allowed to completely dissolve. The patient should not swallow for at least one minute after placing the tablet under the tongue and should not consume food or drink for at least five minutes. A physician experienced in diagnosis and treatment of allergic diseases should supervise administration of the first dose and observe the patient in the office for at least 30 minutes in case of severe allergic reaction. If the first dose is tolerated, subsequent doses can be taken at home. Treatment should be initiated at least 12 weeks before the expected onset of ragweed pollen season and continued throughout the season.

A black box warning cautions that Ragwitek can cause life-threatening allergic reactions and should not be administered to patients who have severe, unstable, or uncontrolled asthma. Patients taking Ragwitek should be prescribed auto-injectable epinephrine and trained in appropriate use. Ragwitek may not be suitable for patients who have underlying medical conditions that could reduce their chance of surviving a serious allergic reaction, or for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as individuals who are taking beta-blockers.

Ragwitek first received FDA approval in 2014.