Savient Pharmaceuticals Inc. (NASDAQ: SVNT), a specialty biopharmaceutical company, focuses on developing, manufacturing, and marketing pharmaceutical products that target unmet medical needs. The company sells and distributes branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss.
Last week, drug regulator FDA said in its briefing documents that the firm's drug Krystexxa (pegloticase) appears effective at treating the symptoms of gout, which is caused by excess uric acid in the body, despite concerns over the drug’s safety. The regulators raised concerns about serious adverse events, including deaths, in patients treated with the drug, Wall Street analysts are confident of drug's approval.
The FDA is scheduled to ask a panel of outside arthritis experts next Tuesday to weigh in on the drugs risks and benefits. Most of the industry experts expect the FDA Arthritis Drugs Advisory Committee to focus more on Krystexxa's ability to fill an unmet medical need for refractory gout than by its safety issues.
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