Dyax Corp. has received FDA approval of DX-88 in hereditary angioedemia (HAE). DX-88 is a recombinant, small protein manufactured in yeast (P. pastoris).

The drug, which will be marketed as Kalbitor, offers a new treatment option for treating acute attacks of HAE, a debilitating disease which causes severe, often painful swelling affecting the extremities (hands, feet, face, etc.), the gastrointestinal tract, the genitalia and, in potentially life-threatening cases, the larynx.

Dyax has worked with Avecia Biologics since 2000 on process development and GMP manufacturing for DX-88. Avecia supported the clinical development programme from Phase I supplies through scale-up, optimization and process validation, and FDA pre-approval inspections for commercial manufacture.

Steve Bagshaw, president of Avecia Biologics, remarked, “We are delighted that Dyax has received FDA approval for Kalbitor. This is the culmination of a long and exciting period of collaboration and we now look forward to continuing to help Dyax bring relief to sufferers of this debilitating disease by ensuring safe, compliant and cost effective manufacturing.”