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The shots, injected just under the skin, typically have been given once or twice a week in increasing doses for 3 to 6 months, followed by a maintenance period of 3 to 5 years with monthly booster shots. More recently, allergy specialists have been using the "cluster" technique, reducing sensitivity faster by giving 2 to 3 dose increases on each of two weekly visits over a month. That's also followed by a maintenance period.
Merck, based in Whitehouse Station, N.J., said it expects the Food and Drug Administration to decide whether to approve the treatment in the first quarter of next year.
It has been approved for several years in Europe, where it is sold under the brand name Grazax by Merck partner ALK-Abello.
Merck wouldn't say Wednesday what it expects to charge for the tablets here. Box noted that when they were launched in Europe in 2006, the price was 2.95 euros per pill, or roughly $3.75 at today's exchange rates. Patients with insurance getting allergy shots typically have a small copay, often $5 or less, because a nurse gives the injections, but all those appointments are time-consuming.
Cox served as the primary investigator in a clinical trial of another grass pollen immunotherapy tablet developed by France's Stallergenes S.A. The FDA accepted that company's application for approval of its experimental treatment on Feb. 18.
Merck recently applied to the FDA for approval to sell an immunotherapy tablet for ragweed pollen. The FDA has not yet determined whether that application is complete enough to accept for review.
Merck, a leader in asthma and allergy treatments with medicines including Singulair, Clarinex and Nasonex, also is doing patient tests of an immunotherapy tablet for house dust mites.
Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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