DYAX ANNOUNCES UPDATE OF DX-88 CLINICAL PROGRAM
Dyax has received guidance in a recent meeting with the FDA's Center for Drug Evaluation and Research, Division of Pulmonary and Allergy Products, regarding the pathway for a biologics license application submission and approval of DX-88 (ecallantide), an orphan drug candidate for treatment of acute attacks of hereditary angioedema.
The FDA concurred that the 30-mg subcutaneous dose is the appropriate dosage and confirmed that a dose-ranging study will not be required. The FDA also said that endpoints used in Dyax's ongoing Phase III trial are acceptable for establishing safety and efficacy. However, the FDA did recommend that a small confirmatory placebo-controlled trial be conducted. This trial will further support the validity of the patient-reported outcome instrument used for demonstrating efficacy in the trial. Dyax agrees with the FDA's recommendation because this trial is in compliance with the new requirements of the "Draft Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims."
Although Dyax has not finalized the scope of the new trial at this time, the FDA has agreed that the new study can be a small, placebo-controlled trial, enrolling both naive and non-naive patients, and that it need only confirm the superiority of the 30-mg dose over placebo.
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