New Ruconest Manufacturing Facility Will Be Built in 2021

Pharming Group has committed to building a new manufacturing facility in the Netherlands to expand production of Ruconest (conestat alfa), its treatment for acute attacks of hereditary angioedema (HAE). Construction will begin in mid-2021. Once finished, it will create at least 40 new jobs, the company said. “With an…

Ruconest Safe, Effective for On-demand and Preventive Treatment of HAE Attacks, Study Says

Ruconest (rhC1INH) is safe and effective as an on-demand therapy to treat acute swelling attacks, and as a short-term prophylaxis to prevent attacks of hereditary angioedema (HAE), a study in Hungary found. Early administration of Ruconest speeds the full resolution of an attack, and repeated use does not…

FDA Rejects Ruconest Label Expansion for HAE Swelling Prevention, Citing Need for More Clinical Data

The U.S. Food and Drug Administration has rejected Pharming’s request to expand the label of Ruconest (conestat alfa) to include routine prevention of swelling attacks caused by hereditary angioedema (HAE). In a complete response letter indicating it had finished its review of the company’s supplemental biologics…