The US Food and Drug Administration (FDA) has approved Pharming Group N.V.’s 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 commercialization in the USA. 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.
CEO Sijmen de Vries says:
“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 HAE for patients in the USA 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.“
(Source: Pharming)
