ALK awaits FDA review on ragweed allergy drug

ALK and Merck Sharpe and Dohme (MSD) have announced the US Food and Drug Administration (FDA) is to review its biologic licence application for an investigational ragweed sublingual allergy immunotherapy tablet. 

The body has scheduled an advisory committee on allergenic products to meet on January 28th 2014 to discuss the application.

A group of independent experts will be gathered to advise the FDA, with the meeting open to the public. These committees are common for new drug classes and potential treatments that are currently under review.

After submitting the initial application in March, ALK and MSD confirmed in May that the ragweed therapy had been accepted for review.

Results from an extensive clinical development programme have formed the basis of the application, with clinical trials demonstrating the treatment reduces allergy symptoms among patients and that the concurrent use of other symptom-relieving medication with the drug does not have any adverse side-effects.