Merck Statement on FDA Advisory Committee for GRASTEK® (Timothy Grass Pollen Allergen Extract), Merck’s Investigational Sublingual Allergy Immunotherapy Tablet

pollen

An allergen is a type of antigen that produces an abnormally vigorous immune response in which the immune system fights off a perceived threat that would otherwise be harmless to the body. Such reactions are called allergies. In technical terms, an allergen is an antigen capable of stimulating a type-I hypersensitivity reaction in atopic individuals through Immunoglobulin E (IgE) responses.[1] Most humans mount significant Immunoglobulin E responses only as a defense against parasitic infections. However, some individuals may respond to many common environmental antigens. This hereditary predisposition is called atopy. In atopic individuals, non-parasitic antigens stimulate inappropriate IgE production, leading to type I hypersensitivity. Sensitivities vary widely from one person (or other animal) to another. A very broad range of substances can be allergens to sensitive individuals.

WHITEHOUSE STATION, N.J., Dec. 12, 2013–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of the Allergenic Products Advisory Committee of the U.S. Food and Drug Administration (FDA) meeting to discuss GRASTEK® (Timothy grass pollen allergen extract). GRASTEK is the proposed trade name for the company’s investigational sublingual tablet for the treatment of Timothy grass induced allergic rhinitis, with or without conjunctivitis, in appropriate adult and pediatric patients who are candidates for immunotherapy.

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An FDA committee has recommended a grass pollen allergen extract for the treatment of Timothy grass pollen-induced allergic rhinitis, with or without conjunctivitis, in individuals aged 5 to 65 years.