Merck ragweed allergy tablet nearing approval

January 28, 2014

An FDA advisory committee has recommended the approval of a ragweed sublingual allergy immunotherapy tablet licensed to Merck.

An FDA advisory committee has recommended the approval of a ragweed sublingual allergy immunotherapy tablet licensed to Merck.

FDA’s Allergenic Products Advisory Committee voted that the available data support the efficacy and safety of Merck’s Ragwitek. 

“This outcome represents another important step forward in the global commercialization of ALK’s SLIT-tablet portfolio,” said Jens Bager, president and CEO of ALK, which produces Ragwitek, but has licensed it to Merck in North America.

FDA is reviewing Merck’s Biologic License Application for Ragwitek, which treats ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age. 

FDA’s review is expected to conclude during the first half of 2014.