Savient Pharmaceuticals, Inc. (SVNT) announced Tuesday that the U.S. Food and Drug Administration acknowledged receipt of and accepted for review the Biologics License Application or BLA for gout drug, Krystexxa, that was resubmitted on March 15. FDA has set September 14 as action date.
Gout is a medical condition that usually presents with recurrent attacks of acute inflammatory arthritis. It is a crystal deposition disease with primarily rheumatological and renal manifestations that results from the long-term effect of monosodium urate crystal deposition in and around joints, on extensor surfaces of tendons, and in other tissues such as the kidney.
Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled at the maximum medically appropriate dose or for whom drugs are contraindicated.
Savient stated that the FDA deemed the resubmission to be a complete, class 2 response and established September 14, 2010 as the PDUFA action date. The resubmitted BLA contained additional chemistry, manufacturing and controls, Safety Update, Labeling, Risk Evaluation and Mitigation Strategy, or REMS, and Medication Guide, as requested in the complete response letter by the FDA in July 2009.
"We look forward to working with the FDA in moving KRYSTEXXA through the regulatory review process over the next few months," noted Paul Hamelin, R.Ph., President of Savient.
Krystexxa, or pegloticase, formerly Puricase, is a treatment for chronic gout in patients refractory to conventional therapy i.e. treatment-failure. Savient licensed worldwide rights to the technology related to Puricase from Duke University and Mountain View Pharmaceuticals, Inc. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc. Also, Savient has an agreement in place with Bio-Technology General, Ltd., a subsidiary of Ferring B.V. of Switzerland, for the phase III clinical and commercial supply for Puricase.
In the past 52 weeks, SVNT has been trading between $4.38 and $16.62 on three month average volume of 787 thousand. SVNT is currently trading at $14.48, up $0.01 on the Nasdaq.
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