Allergy shot alternative

Two new sublingual drugs combat common allergies

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WHITEHOUSE STATION, N.J.—In one week in mid-April, the U.S. Food and Drug Administration (FDA) approved two new allergy products developed by ALK and offered by Merck & Co. Both are said to offer convenient, once-a-day dosing under the tongue, long-term relief from common allergens and the possibility of keeping allergies from developing into asthma while eliminating the need for injections.
 
The Ragwitek short ragweed pollen allergen extract sublingual tablet was approved as immunotherapy to treat short ragweed pollen-induced allergic rhinitis with or without conjunctivitis in adults from 18 to 65 years of age. The grass sublingual allergy immunotherapy tablet known as Grastek was approved as an immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis for use in persons 5 through 65 years of age.
 
ALK entered into a strategic partnership with Merck to develop, register and commercialize a portfolio of sublingual allergy immunotherapy tablets against grass pollen, ragweed and house dust mite allergy in the United States, Canada and Mexico. Under the agreement, ALK will receive up to $290 million in milestone payments from Merck. In addition, ALK is entitled to royalty payments on the net sales of the products on the North American markets as well as payments for product supply. Merck will be responsible for all costs of clinical development, registration, marketing and sales of the products on the North American markets. ALK will be responsible for tablet production and supply. A third drug for allergy to house dust mites went into Phase 3 clinical trials in March in the United States, Europe and Japan.
 
According to Dr. Hendrick Nolte, section head of respiratory clinical research for Merck Research Laboratories, “These drugs are an important alternative to injection therapy. Our vision is to have a portfolio to treat the most important allergens in the United States.”
 
Dr. Nolte related that 6 million adults and 1.5 million children are sensitive to ragweed, and 7.5 million people are sensitive to grass. The new drugs provide treatment options for people who find injections painful or inconvenient.
 
Jens Bager, president and CEO of ALK, explained that some people have such severe allergies that they can barely go outside during the ragweed and pollen seasons. “Patients begin the treatment 12 weeks prior to the season, take it for the duration of the season and build up an immunological tolerance to the allergen,” he said.
 
The tablets rapidly dissolve after being placed under the patient’s tongue. The first dose is given in a doctor’s office, and then subsequent doses are taken at home.
 
Doctors began prescribing Ragwitek in May. In many areas of the United States, ragweed blooms and releases pollen from August to November. Ragweed pollen levels usually peak in mid-September in many parts of the country. Symptoms of ragweed pollen allergies may include sneezing, runny or itchy nose, stuffy or congested nose or itchy and watery eyes. These symptoms typically intensify as the ragweed pollen season progresses.
 
Dr. David Bernstein, an allergy specialist who was involved in the clinical trial for both Grastek and Ragwitek, said that the patients tolerated the treatments very well. He added, “Now patients who don’t have time for shots or who just need to take the drug seasonally can take these pills during the time they need them. There are no compliance issues, because adults can take them when they travel, and pediatric patients can take them during soccer games.”
 
The only reported side effects are itching or swelling under the tongue in about 5 percent of the patients. Another issue that has been raised is the fact that allergy injections tend to treat multiple allergens at the same time. As more sublingual drugs are developed, combining them could be a future option.


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