ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) has voted that the available data support the efficacy and safety of Merck's RAGWITEK™.
RAGWITEK™ is the proposed US trade name of the ragweed sublingual allergy immunotherapy tablet, licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK.
The FDA is currently reviewing Merck's Biologic License Application (BLA) for RAGWITEK™ for the treatment of ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age.
Jens Bager, ALK's President and CEO, said: "This outcome represents another important step forwards in the global commercialisation of ALK's SLIT-tablet portfolio. It follows a similar endorsement of GRASTEK™/GRAZAX® by the Advisory Committee last month."
Although not binding, the FDA will consider the committee's recommendation as it completes its review of the BLA for RAGWITEK™, a process that is expected to be concluded during the first half of 2014.