Pharming Group says FDA grants 12-year product exclusivity to drug for rare genetic disease
Pharming Group NV (Euronext: PHARM) and Salix Pharmaceuticals on Thursday said the US Food and Drug Administration has granted 12 years of exclusivity to the drug for treating a rare genetic disorder.
The determination of exclusivity ensures that FDA will not approve before July 16, 2026 any applications for biosimilars of Ruconest, the companies said in a joint statement.
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.”
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