DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema, and is being evaluated as a subcutaneous therapy for treating acute HAE attacks.
If approved, DX-88 will be the first drug available in the US for treating acute attacks of hereditary angioedema (HAE) and the first subcutaneously administered HAE therapy. The committee’s findings will be weighed by the FDA in determining whether DX-88 is to be approved for marketing.
According to the company, the biological license application submission was based primarily on data from two placebo-controlled Phase III clinical studies, known as EDEMA3 and EDEMA4, which, taken together, represent the largest placebo-controlled evaluation of any therapy used in the treatment of HAE.
Gustav Christensen, president and CEO of Dyax, said: Dyax is grateful to the Committee for their review, and we will consider their recommendations in our ongoing discussions with the FDA. We are committed to establishing safe use conditions for DX-88, if approved, and will work with the FDA to ensure our post-marketing program achieves this goal.