Yes or no vote?
First notice from ScotTrade said this had failed on a 5 to 6 vote. Now DYAX says it was approved on 6 to 5 vote? Seems to be some confusion here. Stock has been halted all day.....
CAMBRIDGE, Mass., Feb 04, 2009 (BUSINESS WIRE) -- Dyax Corp. (NASDAQ:DYAX)
announced today that the U.S. Food and Drug Administration's (FDA)
Pulmonary-Allergy Advisory Committee voted (6 yes, 5 no, 2 abstentions) in favor
of approval of DX-88 (ecallantide) for the treatment of acute attacks of
hereditary angioedema (HAE). If approved, DX-88 will be the first drug available
in the U.S. for treating acute attacks of HAE and the first subcutaneously
administered HAE therapy. HAE is a rare, potentially fatal genetic disorder
characterized by spontaneous episodes of severe, debilitating and often painful
swelling. The Committee's findings will be weighed by the FDA in determining
whether DX-88 is to be approved for marketing.
"Dyax is grateful to the Committee for their review, and we will consider their
recommendations in our ongoing discussions with the FDA," said Gustav A.
Christensen, President and Chief Executive Officer of Dyax. "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. We look forward to
bringing DX-88 to HAE patients living with this devastating disease."
According to a recent Burden of Illness study sponsored by the United States
Hereditary Angioedema Association and Dyax(1), the average HAE patient
experiences more than 26 acute attacks per year. Approximately half of the study
respondents reported missing school or work as a result of any given acute
attack, with a typical attack lasting an average of more than two and a half
days. Attacks can occur in any part of the body, becoming life-threatening when
affecting the larynx. Study respondents reported experiencing considerable
long-term burden in addition to the immediate pain and suffering associated with
acute attacks, including depression, missed opportunities, deterioration of
mental and physical health and overall decreased productivity.
The BLA submission was based primarily on data from two placebo-controlled Phase
3 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.
About DX-88 for HAE
The recombinant, small protein, DX-88 (ecallantide), was discovered utilizing
Dyax's proprietary phage display technology. DX-88 is a potent and selective
plasma kallikrein inhibitor, a key mediator of inflammation in angioedem |
