WASHINGTON, Feb 2 (Reuters) - U.S. drug reviewers have raised questions about effectiveness data supplied by Dyax Corp (DYAX.O: Quote, Profile, Research, Stock Buzz) to back its experimental drug to treat a rare swelling disorder, documents released on Monday said.
A Food and Drug Administration advisory panel meets on 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."
Dyax shares fell 3.3 percent to $3.25 in morning trading on Nasdaq.
Hereditary angioedema, or HAE, is an inherited disorder that causes painful swelling of the skin, intestine, throat and mouth. The throat swelling can be life-threatening.
Dyax, in a separate summary prepared for the advisory panel, said its studies showed ecallantide was safe and effective in relieving symptoms from an HAE attack. The company said there was a need for the drug as there are no-FDA approved treatments for managing acute attacks.
Market Data 
Markets 
AI
