Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based Savient Pharmaceuticals has announced that the FDA has accepted for review the company's biologics license application for pegloticase, a biological drug for treatment-failure gout patients.
Subscribe to our email newsletter
The FDA also granted the company’s biologics license application (BLA) with a priority review status which accelerates the review period to six months.
A priority review designation is assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. Under priority review, the target date for an FDA decision on the pegloticase BLA is April 30, 2009.
The BLA submission is based on the two replicate, six-month Phase III clinical trials, performed under the auspices of a special protocol assessment. Additionally, the company’s BLA includes data from the open-label extension study for pegloticase, per the request of the FDA.
Pegloticase (formerly referred to as Puricase) is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective.
Savient Pharmaceuticals is a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical products in unmet medical needs in Rheumatology and other medical markets.