FDA Approves Merck's Ragwitek For Ragweed Pollen-Induced Allergic Rhinitis
By Cyndi Root
Merck announced in a press release that the Food and Drug Administration (FDA) has approved Ragwitek. The tablet is the first and only sublingual allergen immunotherapy treatment for short ragweed pollen-induced allergic rhinitis with or without conjunctivitis. The treatment is for adults who are positive for pollen-specific IgE antibodies for short ragweed pollen. Dr. David Skoner, a clinical investigator for Merck said, "While there are regional variations, ragweed season typically starts in mid-August across the United States. 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."
Ragwitek
Ragwitek is available by prescription and is administered sublingually, under the tongue once daily. The immunotherapy is approved for adults, people 18 to 65 years old. The medication does not provide immediate relief of symptoms. Instead, it is a preventative medicine, taken 12 weeks before ragweed season and during the season. In the U.S., ragweed season starts in August and continues through November, peaking in September, although there are variations according to geographical region. Patients seeking allergy relief should visit a physician now to plan treatment. Ragwitek is not indicated for asthma patients or those with eosinophilic esophagitis.
Short Ragweed Pollen Allergy
Short ragweed pollen allergy is a fall allergy, also known as hay fever or allergic rhinitis. Up to 30 percent of Americans suffer from this condition and it often runs in families. Ragweed, from the genus Ambrosia, gives off pollen that causes symptoms like sneezing, runny nose, and itchy eyes. Some people may also contract conjunctivitis, inflammation in the eye, also called pink eye. Ragweed pollen causes the immune system to mount a response of antibodies that start a chain reaction and release the histamine responsible for allergy symptoms.
FDA Action
In a press release issued by the FDA, the federal agency states that Ragwitek was studied in about 1,700 adults. Studies were placebo-controlled, and investigators evaluated effectiveness, safety, and adverse events. The patients who received the drug experienced a 26 percent reduction in allergy symptoms compared to the placebo group. Adverse reactions included itchy mouth, ears, and throat.
Catalent Pharma Solutions manufactures Ragwitek for Merck, Sharp & Dohme Corp., a subsidiary of Merck and Co., Inc. of Whitehouse Station, N.J.