FDA Approves Ragwitek Under-the-Tongue Hay Fever Pill

THURSDAY April 17, 2014, 2014 -- A novel treatment for the hay fever that plagues millions of Americans every fall was approved Thursday by the U.S. Food and Drug Administration.

The first hay fever pill to be placed under the tongue once a day, Ragwitek can be taken by adults aged 18 to 65, the FDA said in a news release.

Treatment is typically started three months before the start of ragweed pollen season, and patients keep taking it throughout the season. The first dose is taken in a health care professional's office, so the patient can be monitored for any adverse reactions to the pill. After that, Ragwitek can be taken at home, the FDA said.

"The approval of Ragwitek offers millions of adults living with ragweed pollen allergies [hay fever] in the United States an alternative to allergy shots to help manage their disease," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the news release.

A product of Merck & Co., Ragwitek is made of ragweed pollen and helps the body become immune to it. In the United States, the ragweed season usually starts in September and runs through the fall.

People suffering from ragweed allergy suffer stuffy noses with sneezing, itching and congestion, as well as itchy and watery eyes. These annoying symptoms can affect quality of sleep and hamper daily activities. Plus, these problems often precede the development of asthma.

Current treatments include a variety of nasal sprays, as well as shots specifically tailored to tame all of a patient's allergies.

Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, has expressed doubts in the past about the power of the new pill. He said people who are allergic to ragweed often are allergic to other plants as well.

"I am skeptical that the pill will work on these other plant allergies," he told HealthDay.

Another expert, however, said he sees this as a first step in making this kind of allergy treatment a possibility.

"The whole idea of [under-the-tongue] immunotherapy has been in the background for some time," said William Blouin, an allergy and immunology nurse practitioner at Miami Children's Hospital. "Until this point, immunotherapy has to be done as a series of injections."

A pill would make life simpler, he said, because it wouldn't require the inconvenience of weekly doctor visits or the pain of injections. Blouin said the new pill is intended only for ragweed, so if a person were allergic to other plants it would mean taking a separate pill for each one.

Last December, an FDA advisory committee voted unanimously to recommend approval of a similar kind of pill for grass pollen allergies, known as Grastek. Merck is developing that pill in partnership with a European company.

The FDA based Thursday's approval on the results of safety studies involving approximately 1,700 patients. Some of the patients who were treated with Ragwitek experienced itching in the mouth, and ear and throat irritation. Of the 1,700 patients, about 760 were evaluated for effectiveness. During one ragweed pollen season, patients who received Ragwitek saw a 26 percent reduction in symptoms and the need for medications, compared to those who received a placebo, the FDA said.

More information

Visit the American College of Allergy, Asthma and Immunology for more on ragweed allergy.

Posted: April 2014


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