FDA Approves Merck's Ragwitek for Hay Fever Treatment

The U.S. Food and Drug Administration has approved Merck & Co's pollen allergy drug Ragwitek for hay fever.

The drug is the first allergen extract administered under the tongue (sublingually). Ragwitek is to be used for treatment for short ragweed pollen induced allergic rhinitis (hay fever) with or without conjunctivitis in people between ages 18 and 65 years.

Allergies, including allergic rhinitis, affect some 40 to 50 million people in the U.S. Short ragweed pollen is one of the most common seasonal allergen during late summer in the country.

Symptoms of an allergic reaction to the pollen include runny nose, repetitive sneezing, nasal itching and congestion along with itchy eyes. People can avoid the allergic reaction by minimizing contact with the pollen, using medication for the symptoms and taking allergy shots.

 "The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, according to a statement.

According to FDA, the pollen extract treatment can be started 12 weeks before the beginning of ragweed pollen season and then throughout the season. The first dose is to be administered at a doctor's office to assess patients' reaction to the treatment. The patients can take subsequent doses at home.

Ragwitek's safety and efficacy was tested on various studies conducted in the U.S. and in other countries. In all, 1,700 adults participated in the research.

Of the 1,700 people, 760 participated in the drug-effectiveness trial. Some of the participants received Ragwitek while other received a placebo pill. Researchers found that patients using Ragwitek experienced a 26 percent reduction in their symptoms.

"The FDA approval of RAGWITEK brings an important new option for allergy specialists treating adults with allergic rhinitis with or without conjunctivitis caused by short ragweed pollen," said Dr. Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories, according to a press statement.

It is important to note that Rigwitek comes with severe allergic reactions.

Merck's grass allergy drug Grastek was also recently approved by the U.S FDA.