Allergy Therapeutics today provides an update on the clinical hold that has been placed by the United States Food and Drug Administration (‘FDA’) on the Company’s product development programmes. On 11 July 2007 the Company announced that activity on its clinical studies had been placed on hold by the FDA whilst the Agency fully assessed the report of a rare adverse event classified at that time by the physician involved as ‘possibly related’ to the study drug.
The Company has now had a ‘Type A’ meeting with the FDA. Prior to the meeting Allergy Therapeutics submitted a comprehensive package of information to the Agency. The meeting was constructive and resulted in a better mutual understanding of the position regarding the Company’s development programmes. The FDA has indicated that it is in the process of conducting a thorough review. The Company will make further submissions in the coming weeks and will continue to work with the FDA to lift the clinical hold.
A further announcement will be made as and when appropriate.
For further information
Allergy Therapeutics +44 (0) 1903 845 820
Keith Carter, Chief Executive
Tom Holdich, R&D Director
Landsbanki +44 (0) 207 003 3131
Shaun Dobson
Financial Dynamics +44 (0) 207 831 3113 Ben Brewerton
