News Feature | February 4, 2014

Merck Wins Canadian Regulatory Approval To Launch GRASTEK® ® Sublingual Tablet

Source: Pharmaceutical Online

By Estel Grace Masangkay

Merck today announced the Canadian regulatory approval and simultaneous launch of its allergy immunotherapy tablet GRASTEK®. The regulatory green light marks the first approval of GRASTEK® for Merck.

Merck will launch GRASTEK® (Timothy grass pollen allergen extract) in Canada as sublingual tablets. Merck developed GRASTEK® in collaboration with Denmark-based ALK-Abello for the treatment of ragweed pollen, Timothy grass pollen, and house dust/mite induced allergic rhinitis. GRASTEK® is currently marketed as GRAZAX by Merck’s partner ALK-Abello in the European Union.

Allergic rhinoconjunctivitis (ARC) affects more than 500 million patients worldwide, with an estimated 30 million patients in the U.S. alone. Allergen avoidance and pharmacotherapy are usually recommended for patients but a significant percentage remains affected with symptoms. In these cases, allergen immunotherapy is deemed a reasonable treatment.

Sublingual treatment or taking allergen extracts orally is a recent development seen in the U.S. and across Europe. The method is preceded by subcutaneous allergen immunotherapy (SCIT), used since the early 20th century. U.S.-licensed allergen extracts approved for exclusive SCIT use include mold spores, animal danders, and pollens.

GRASTEK® is designed to help target and treat underlying causes of allergic rhinitis through activation of the body’s own immune response against Timothy grass pollen. Each sublingual tablet contains 2,800 bioequivalent allergy units (BAU) of GRASTEK®’s drug substance. GRASTEK®’s standardized allergen extract from Timothy grass pollen (Phleum pratense) is sourced from the U.S.

GRASTEK® is indicated in adult patients (18 to 65 years of age) and children (five years of age and up) for the treatment of grass pollen induced allergic rhinitis with or without conjunctivitis in Canada. The recommended dose is one sublingual tablet per day.

GRASTEK® is presently awaiting approval from the U.S. Food and Drug Administration (FDA). The FDA has previously accepted for review GRASTEK®’s Biological License Applications and its investigational ragweed sublingual allergy immunotherapy tablet. The company expects both FDA reviews to be completed by the second quarter of this year.