Savient's KRYSTEXXAÂ® (pegloticase) Receives European Commission Marketing Authorization For The Treatment Of Certain Patients With Chronic Tophaceous Gout
BRIDGEWATER, N.J. and DUBLIN, Jan. 8, 2013 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) and its wholly owned subsidiary, Savient Pharma Ireland Ltd., today announced that the European Commission has granted a marketing authorization for KRYSTEXXA ® (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
"There is currently no other treatment option in the EU for patients with severe chronic tophaceous gout who do not respond to oral xanthine oxidase inhibitors," said Dr. Thomas Bardin, MD, Professor and Head of the Rheumatology department at the Lariboisière Hospital in Paris, France. "KRYSTEXXA addresses a significant unmet medical need and represents an important development for healthcare professionals and European patients suffering from this debilitating disease."
"European approval of KRYSTEXXA demonstrates our ongoing commitment to this underserved population by offering a much needed treatment option to these patients and marks a significant milestone for the Company," said Lou Ferrari, President and Chief Executive Officer of Savient. "We continue to establish relationships with clinicians and key opinion leaders in Europe, and we anticipate product launch in the region by mid-2013."
The European Commission's approval decision was based upon safety and efficacy data from Savient's two pivotal Phase III studies, and a long-term open label extension study of KRYSTEXXA, as well as non-clinical and chemistry, manufacturing and control information.Until the product becomes commercially available in the EU, Savient will continue to provide KRYSTEXXA to patients through the established Named Patient Programme (NPP).
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV