News

Avecia Biologics customer achieves FDA approval

Date: 02/12/2009

Avecia Biologics customer achieves FDA approval to market a biologic to treat acute attacks of Hereditary Angioedema (HAE)

Billingham, UK, 2 December 2009 : Avecia Biologics has announced that Dyax Corp. (NASDAQ: DYAX), a customer for whom it has worked since 2000 on process development and GMP manufacturing, has received FDA approval of DX-88 in HAE. DX-88 is a recombinant, small protein manufactured in yeast (P. pastoris). The drug, which will be marketed as KALBITOR® (ecallantide), 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.

Avecia Biologics supported the clinical development programme of KALBITOR from Phase I supplies through scale-up, optimisation and process validation, and FDA pre-approval inspections for commercial manufacture.

Steve Bagshaw, President Avecia Biologics, said “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.”


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