Santarus, Inc. (SNTS) and Pharming Group NV (PHGUF.OB) announced that the U.S. Food and Drug Administration or FDA has accepted for filing the Biologics License Application or BLA for the investigational drug RUCONEST 50 IU/kg. Both the companies are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema.
As part of its review, the FDA plans to present the BLA to the Blood Products Advisory Committee. According to the Prescription Drug User Fee Act guidelines, Santarus and Pharming anticipate that the FDA would complete its review or otherwise respond to the RUCONEST BLA by April 16, 2014.
The safety and efficacy of RUCONEST for HAE attacks treatment were assessed in a clinical program that included a Phase III randomized placebo-controlled trial conducted under a Special Protocol Assessment agreement with the FDA. Also, the RUCONEST program included two additional randomized placebo-controlled studies and several open label treatment studies.
"RUCONEST is the first recombinant C1 esterase inhibitor developed with the goal of treating the pain and swelling associated with acute HAE attacks," said Gerald Proehl, president and chief executive of Santarus.
Santarus licensed certain exclusive rights from Pharming to commercialize RUCONEST in North America for the treatment of acute attacks of HAE and other potential future indications. Pursuant to the license agreement, a $5 million milestone is payable to Pharming as a result of the FDA acceptance for review of the BLA for RUCONEST.
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