FDA Advisory Committee meeting unanimously recommends approval of GRASTEK (GRAZAX®)

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 unanimously that the available data support the efficacy and safety of Merck's GRASTEKTM in patients aged five to 65 years. The committee further recommended that adrenaline auto-injectors should be made available for patients at home. 

GRASTEKTM is the proposed US trade name of the grass sublingual allergy immunotherapy tablet, licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX®.  

The FDA is currently reviewing Merck's Biologic License Application (BLA) for GRASTEKTM for the treatment of grass pollen induced allergic rhinitis, with or without conjunctivitis, in adults and children of five years and older. 

Jens Bager, ALK's President and CEO, said: "ALK welcomes the FDA Advisory Committee's conclusion, which represents another important step towards bringing this innovative new treatment to US patients."  

Although not binding, the FDA will consider the committee's recommendation as it completes its review of the BLA for GRASTEKTM, a process that is expected to be concluded during the first half of 2014. 

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