Dyax Receives FDA Approval For Kalbitor

RCT licensee, Dyax has received approval from the FDA for Kalbitor (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

Reportedly, the approval of Kalbitor is a product produced in the Pichia pastoris yeast expression system. Tucson-based Research Corporation Technologies (RCT) has licensed the Pichia system to numerous companies in the biotechnology, pharmaceutical, animal health and food industries.

Kalbitor, a potent, selective and reversible plasma kallikrein inhibitor discovered and developed by Dyax, is the first subcutaneous HAE treatment approved in the US.

Kurt Gehlsen, chief scientific officer at RCT, said: “We are pleased by the approval of Kalbitor for the treatment of HAE, and the fact that our Pichia technology played a role in the development of this product. We expect that this will be the first of many new biologic-based products to be produced in Pichia.”