The FDA has conferred its coveted breakthrough-therapy designation to Dyax’s ($DYAX) lead pipeline asset, an antibody designed to treat flare-ups of the rare hereditary angioedema (HAE).
Breakthrough status guarantees Dyax access to senior staff as it develops DX-2930, giving the biotech an inside track at the agency and making the treatment eligible for a shortened review process once the biotech submits it to regulators. HAE, which affects about 1 in every 50,000 people, is an inflammatory ailment that results in bouts of severe swelling.
Dyax’s subcutaneous treatment, which blocks the enzyme plasma kallikrein, significantly lowered patients’ average number of weekly HAE attacks compared with placebo in Phase Ib results disclosed in March. The antibody also met all of its safety, tolerability and pharmacokinetic goals, the company said, and Dyax is planning to launch a Phase II study later this year.
Read more at the source. Article by Damian Garde