FDA grants fast track designation for bladder cancer treatment
IRVINE, Calif. Spectrum Pharmaceuticals and Allergan, Inc. announced that the Food and Drug Administration has granted fast track designation for the investigation of apaziquone for the treatment of non-muscle invasive bladder cancer, a form of bladder cancer localized in the surface layers of the bladder that has not spread to the deeper muscle layer.
Approximately 70% of all newly diagnosed patients with bladder cancer have non-muscle invasive bladder cancer, the companies said. More than one million patients in the United States and Europe are estimated to be affected by the disease.
“We are pleased that the FDA has accepted apaziquone under its fast track program,” said Rajesh C. Shrotriya, chairman, president and CEO of Spectrum Pharmaceuticals. “In a marker lesion study, where patients had previously failed multiple therapies, apaziquone produced a 67% complete response and was well-tolerated. We look forward to continuing with Phase 3 studies evaluating the efficacy and safety of apaziquone, while working with the FDA to expedite the drug’s development, review and approval process so we can help address the substantial unmet needs of patients suffering from non-muscle invasive bladder cancer.”
Fast track designation is designed to facilitate drug development and expedite the review of drugs intended to treat serious conditions and demonstrate the potential to address unmet medical needs.
Human Genome Sciences, GSK announce trial results for systemic lupus treatment
ROCKVILLE, Md. An investigational biotech drug for treating systemic lupus has done well in late-stage clinical trials so far, the two companies developing the drug announced Monday.
Human Genome Sciences and GlaxoSmithKline announced that the drug Benlysta (belimumab) met its primary efficacy goal in BLISS-52, the first of two phase 3 trials comparing it to standard methods of care and placebo in patients with systemic lupus erythematosus, also known as SLE. The companies said Benlysta was the first lupus drug to reach this advanced a stage in clinical development.
“The BLISS-52 results demonstrate that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus,” Human Genome Sciences president and CEO H. Thomas Watkins said in a statement. “Given the limited treatment options currently available, patients would benefit greatly from potential new treatments.”
The two companies entered an agreement to develop and commercialize Benlysta in August 2006.
FDA approves two additional strengths of generic schizophrenia drug
PITTSBURGH The Food and Drug Administration has approved two additional strengths of a generic version of a common schizophrenia drug.
Mylan announced Monday the approval of its haloperidol tablets in the 10 mg and 20 mg strengths. The company already markets the drug in strengths of 0.5 mg to 5 mg.
Haloperidol is used to control the symptoms of schizophrenia and Tourette syndrome and is a generic version of Johnson & Johnson’s Haldol, though J&J no longer manufactures Haldol in the tablet form. Haloperidol had sales of $21 million for the 12 months ending in March, according to IMS Health data.