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Pharmaceuticals / Regulatory Affairs

FDA Grants Orphan Drug Status to Dyax’s DX-2930 for Hereditary Angioedema

Dec. 6, 2013

Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says.

The small-volume, subcutaneous injection is currently being studied in a Phase I trial in the U.S., the results of which are expected in the first quarter of 2014. After that, says Dyax spokesperson Jennifer Robinson, the company plans to move on to Phase Ib and Phase II trials, contingent upon discussions with the FDA. Dyax would like to expand its trial patient base into the EU in Phase II and eventually move on to Phase III studies, though it does not yet have a set timeline.

Orphan drug designation, assigned to products that treat diseases affecting less than 200,000 U.S. patients, provides Dyax with agency assistance in trial design, exemption from user fees and seven years of market exclusivity after approval. — Lena Freund

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