Pharming Group has received US FDA approval of its Prior Approval Supplement to add the new Netherlands production facility of starting material to the Biologics License Application (BLA) to support its lead product, RUCONEST.
With the addition of this new facility for US supplies as well, Pharming can continue to expand sales in all markets in the coming year.
Pharming is now also able to release the product that is manufactured with starting material from the facility for commercialisation in the US. As previously announced, Pharming had already received approval for output from the new facility from the European Medicines Agency for commercial use in the European Union.
Sijmen de Vries, Chief Executive of Pharming, said: “We are pleased to announce this approval by the FDA of our new facility, which will enable us to meet increasing demand for RUCONEST in the treatment of hereditary angioedema for patients in the US as well as for those in the EU. Following on from the EMA approval announced earlier this year in January, this gives us sufficient capacity for current demands as we continue to build for the future.
RUCONEST (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of acute Hereditary Angioedema (“HAE”) attacks in patients in Europe, the US, Israel and South Korea. The product is available on a named-patient basis in other territories where it has not yet obtained marketing authorisation.
