Ragwitek Approved by FDA: A Sublingual Pill for Hay Fever

Key Takeaways:

• The FDA has approved Ragwitek, a sublingual pill intended for the treatment of hay fever, or ragweed pollen allergies. The pill is the first of its kind, to be placed under the tongue once daily, and is usable by adults aged between 18 and 65.
• Treatment with Ragwitek typically begins three months before the ragweed pollen season and continues throughout the season. After the first dose administered in a healthcare setting, subsequent doses can be taken at home.
• Ragwitek may provide an alternative to allergy shots for managing hay fever. The pill is made of ragweed pollen, which assists the body in building immunity against it.
• Despite its benefits, there’s some skepticism about the effectiveness of the pill for patients with allergies to multiple plants. However, it could pave the way for more simplified allergy treatments, eliminating regular doctor visits and injections.
• Approval of Ragwitek followed safety research involving approximately 1,700 patients. Patients treated with the pill experienced a decrease in symptoms by 26%, and a reduced need for medications, compared to those treated with a placebo, although side effects include itching in the mouth and ear and throat irritation.

The bane of millions of American’s existence each fall, hay fever, might just have found its novel treatment. The United States’ Food and Drug Administration recently approved the treatment that might prove to be a lifesaver for hay fever patients.

Meet Ragwitek, the first hay fever pill of its kind that is placed under the tongue once daily. Adults aged between 18 and 65 can use this drug, as stated by the FDA.

How Does The Treatment Work?

Typically, the treatment begins three months before the onset of the ragweed pollen season. Patients continue to take the drug throughout the season. The first dose is administered in a healthcare professional’s office. This is to monitor the patient for any adverse reactions to the pill. Upon subsequent doses, the pill can be taken from the comfort of your own home, as stated by the FDA.

“Ragwitek provides an alternative treatment to millions of adult hay fever sufferers [ragweed pollen allergies] in the United States. It can be an alternative to allergy shots used to manage their condition,” stated Dr. Karen Midthun, the director of the FDA’s Center for Biologics Evaluation and Research.

A creation of Merck & Co., Ragwitek is made of ragweed pollen which assists the body in building immunity against it. Usually, the ragweed season in the U.S commences in September and lasts throughout the fall.

Evidence of Need

Patients suffering from a ragweed allergy usually present symptoms like sniffles, sneezes, itching, and congestion, as well as itchy, watery eyes. These irritating symptoms are regular sleep disturbers in addition to their hindrance of daily activities. They may also lead to the development of asthma.

Since patients suffering from ragweed allergy often exhibit reactions to other plants as well, Dr. Len Horovitz of Lenox Hill Hospital in New York City expressed skepticism about the effectiveness of the pill for these concomitant allergies.

Other Opinions

However, another expert, William Blouin, an allergy, and immunology nurse practitioner at Miami Children’s Hospital, sees Ragwitek as the beginning of easing allergy treatments.

People suffering from allergies to multiple plants would need a separate pill for each allergic reaction. Hence, this pill would make things more straightforward, eliminating the inconvenience of weekly doctor’s visits and the discomfort of injections.

The new pill’s approval comes in the wake of the FDA advisory committee’s unanimous vote last December, in favor of a similar pill, Grastek, for treating grass pollen allergies. This pill is being developed by Merck in partnership with a European company.

To support the approval, the FDA referred to safety research involving approximately 1,700 patients. Patients treated with Ragwitek experienced side effects including itching in the mouth and ear and throat irritation. Out of these 1,700 patients, about 760 were evaluated for effectiveness. During a ragweed pollen season, those treated with Ragwitek experienced a decrease in symptoms by 26%, and a reduced need for medications, compared to those treated with a placebo, the FDA stated.

More Information

For more information on ragweed allergies, visit the American College of Allergy, Asthma and Immunology.