Pegloticase BLA filing accepted for priority review by FDA
Significant local and international variations in the diagnosis and treatment of attention deficit-hyperactivity disorder (ADHD) stem at least in part from a “zone of ambiguity”–different interpretations of what is normal behavior and what level of impairment is required for a psychiatric diagnosis. Furthermore, the long-term effectiveness of different treatments is unclear. These are among
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Savient Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s Biologics License Application (BLA) for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients.
The FDA also granted the Company’s 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 3 clinical trials, performed under the auspices of a special protocol assessment. Additionally, the Company’s BLA includes data from the open label extension (OLE) study for pegloticase, per the request of the FDA. The OLE study allowed those patients who completed the Phase 3 trials to continue or begin receiving pegloticase for an extended period of time. The data set includes 101 patients with at least twelve months of continuous treatment. Pegloticase was previously granted orphan drug designation by the FDA.
Treatment-failure gout occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with allopurinol at the maximum medically appropriate dose or for whom allopurinol is contraindicated.
Pegloticase (formerly referred to as Puricase(R)) 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. The two Phase 3 pivotal trials assessed the safety and efficacy of a six-month course of pegloticase therapy in patients with treatment-failure gout, under the auspices of an SPA from the FDA. Savient has licensed exclusive worldwide rights to the technology related to pegloticase from Duke University and Mountain View Pharmaceuticals, Inc. Puricase(R) is a registered trademark of Mountain View Pharmaceuticals, Inc.
Researchers in the U.S. say a new drug effectively treats serious cases of gout - the drug called pegloticase mimics a blood-clearing enzyme missing in humans and helps remove the build up in uric acid, which causes the painful, needle-like crystals to collect around fingers, toes and other joints. Pegloticase made by the Savient
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Dyax Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review. Based on this designation, the FDA Prescription Drug User Fee Act (PDUFA)
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Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout. The vote was 12 to zero in favor of
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Barr Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.’s Adenovirus Types 4 and 7 Live Oral Vaccines Biologics License Application (BLA). These oral vaccines represent Barr’s first in-house biologics development initiative and demonstrate the Company’s ability to develop, manufacture and conduct clinical trials for
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Roche and Memory Pharmaceuticals has announced that the two companies have signed a definitive merger agreement for Roche to acquire all the outstanding shares of Memory Pharmaceuticals in an all-cash transaction for an aggregate price of approximately USD 50 million. Memory Pharmaceuticals develops innovative drug candidates for the treatment of debilitating central nervous system (CNS)
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