FDA Advisory Committee to Review Ragweed Sublingual AIT Tablet


ALK announces FDA to   AIT

Allergenic Products Advisory Committee meeting scheduled for 28 January 2014.

COPENHAGEN, Dec. 26, 2013 (GLOBE NEWSWIRE) –ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the US Food and Drug Administration (FDA) has scheduled an FDA Allergenic Products Advisory Committee meeting to be held on 28 January 2014 to discuss the Biologic License Application (BLA) for the investigational ragweed sublingual allergy immunotherapy (AIT) tablet.

FDA advisory committees are panels of independent experts who advise the agency as they consider regulatory decisions. Advisory committee meetings are open to the public and are common for new drug classes and/or major pharmaceutical drugs under review.

In March 2013, ALK’s partner for North America, Merck (NYSE:MRK), known as MSD outside the United States and Canada, submitted the BLA to the FDA for the sublingual allergy immunotherapy tablet against ragweed allergy. In May 2013, ALK and Merck announced that the BLA was accepted for review by the FDA.

Merck’s application is based on results from an extensive clinical development pro-gramme. Data from the clinical trials have demonstrated that treatment with ragweed sublingual AIT tablets reduces patients’
allergy symptoms and their concomitant use of symptom-relieving medication and that the treatment is well tolerated.

ALK’s partnership with Merck covers the development, registration and commer-cialisation of a portfolio of sublingual allergy immunotherapy tablets in North America.

                             ALK-Abello A/S
                               Jens Bager
                            President & CEO

For further information please contact:Jens Bager, President and CEO, tel. +45 4574 7576Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525Press: Martin Barlebo…Read more

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