February 2, 2009 / 2:32 PM / 11 years ago

US FDA staff question data on Dyax drug

WASHINGTON, Feb 2 (Reuters) - U.S. drug reviewers have raised questions about effectiveness data supplied by Dyax Corp DYAX.O to back its experimental drug to treat a rare swelling disorder, documents released on Monday said.

A Food and Drug Administration advisory panel meets Wednesday to review the drug, ecallantide, as a possible treatment for hereditary angioedema.

In a summary prepared for the panel, FDA statistical reviewers said “issues identified in the phase 3 studies suggest that there is a lack of consistent and substantial evidence to support the efficacy claim of ecallantide.” (Reporting by Lisa Richwine; editing by Gerald E. McCormick)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below