Denmark-based allergy specialist ALK Abello (ALKB: DC) is the first pharma casualty of the US government shutdown. The company said today that the US Food and Drug Administration has temporarily postponed the Allergenic Products Advisory Committee meeting scheduled for November 6 to discuss the Biologic License Application for the investigational grass allergy immunotherapy (AIT) tablet.
The FDA has not yet confirmed a new date for the Advisory Committee meeting. ALK said it will provide an update when additional information becomes available.
In January 2013, ALK’s partner for North America, pharma giant Merck & Co (NYSE: MRK), submitted the BLA to the FDA for the disease-modifying tablet against grass pollen allergy. In March 2013, ALK and Merck announced that the BLA was accepted for review by the FDA.
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