FDA grants HAE drug Ruconest 12-years of exclusivity

Salix, a division of Valeant Pharmaceuticals, and Pharming have announced that the US Food and Drug Administration (FDA) has granted 12 years of exclusivity to Ruconest (C1 Esterase Inhibitor [Recombinant]), ensuring that the FDA will not approve any applications for biosimilars of the drug before 16 July 2026.

Ruconest was approved by the FDA in July last year for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE).

A rare condition occurring in about 1 in 10,000 to 1 in 50,000 people worldwide, HAE is potentially life-threatening and stems from a genetic defect that impacts the production of C1-INH protein.  This can lead to a biochemical imbalance that causes swelling in various parts of the body, including the hands, feet and face. Swelling in the intestinal wall can also cause severe abdominal pain, nausea and vomiting. Due to its rarity, many patients often remain undiagnosed for years.

Commenting on the exclusivity, Deb Jorn, Executive Vice President/Company Group Chairman, Valeant Pharmaceuticals, said, “We are pleased the anticipated exclusivity for RUCONEST has been formally granted. The response to Ruconest has been positive since its launch in November 2014 and we look forward to continued growth.”

Sijmen de Vries, Pharming’s CEO, added, “Pharming strived to make Ruconest available to the HAE patient community in the US, because we were aware of the great value and benefits that Ruconest could provide to patients.  That the FDA granted 12 year exclusivity for Ruconest reinforces this long-standing commitment and we are excited to continue to work closely with Salix to ensure patients in the US have access to Ruconest.”