Wednesday, December 2, 2009

Dyax drug wins FDA approval for rare swelling disorder

By Julie M. Donnelly

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The U.S. Food and Drug Administration (FDA) has granted Dyax Corp. approval for a drug called Kalbitor to treat a rare genetic disorder that causes severe swelling.

The drug is designed to treat acute attacks of hereditary angioedema in patients 16 years of age and older. HAE causes debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway. 

Kalbitor is the first under-the-skin treatment for the disease approved in the U.S.
 
“Bringing Kalbitor to market validates our mission to discover, develop, and commercialize innovative biopharmaceuticals for unmet medical needs,” said Gustav A. Christensen, president and CEO of Dyax, in a statement.

Often striking patients more than 20 times a year, HAE attacks are unpredictable and range in progression and severity. An acute episode may occur in one or more anatomical sites, sometimes moving from one site to another.

Cambridge-based Dyax conducted two Phase 3 studies on the drug, including a total of 143 patients.

Dyax, along with the FDA, has established a Risk Evaluation and Mitigation Strategy (REMS) program to communicate the risk of anaphylaxis — a severe allergic reaction. Of all the patients who used the drug, 3.9 percent experienced anaphylaxis.

Dyax’ stock surged over 20 percent on the news to $4.21 in midday trading Wednesday, up from $3.50 at the previous close.