(By Salman - iStockAnalyst Writer)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.

In a research note to clients, Collins Stewart analyst Salveen Kochnover wrote that the FDA's review struck a "positive tone," and did not include any surprises. "We are very encouraged with the FDA's listed items for discussion and believe they seem biased toward approval of Krystexxa" he added. He said Savient's drug can likely win approval so long as the company agreed to limit its use to the target patient population and closely monitor negative side effects. The company is specifically seeking an indication for gout patients who are not receiving relief from other treatments.

Leerink Swann analyst Joseph Schwartz said he was encouraged by the roster of the voting members, which is dominated by many of the same rheumatologists who also had voted in favor of Takeda Pharmaceutical Co. Ltd.'s gout drug Uloric (febuxostat). Due to the rheumatologists' understanding of the unmet medical need in TFG, he expects them to vote in favor of Krystexxa.

Similarly Cowen & Co. analyst Eric Schmidt said that Savient's management "has conveyed to us that they are willing to do what it takes to get Krystexxa approved." While predicting the ultimate outcome of Tuesday's panel remains difficult, Schmidt said the "relatively benign nature" of the review documents made him "modestly more optimistic" for a recommendation for approval with a stringent risk evaluation and mitigation strategy program.