Operational updates
Pharming Receives Complete Response Letter from FDA
Pharming Group N.V. announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the supplemental Biologics License Application (sBLA) for RUCONEST® [C1 Esterase Inhibitor (recombinant)] to expand the current indication to include prophylaxis in patients with hereditary angioedema (HAE).
“We see this as a minor setback. Pharming remains committed to serving the HAE community.”
- Sijmen de Vries - CEO