Salix Pharmaceuticals and Pharming Group have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date to 16 July 2014 for the Biologics License Application (BLA) for the investigational drug Ruconest 50 IU/kg.
The marketing approval of Ruconest is for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).
Ruconest (conestat alfa) is a recombinant human C1 esterase inhibitor approved to treat angioedema attacks in HAE patients in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum.
Currently, the product is also being evaluated for various follow-on indications.
Salix develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases.
The company's strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission of these products, and market them through its gastroenterology specialty sales and marketing team.
Pharming Group, which develops new products for the treatment of unmet medical needs, has a GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell based technologies.
