U.S. FDA panel urges approval of Savient gout drug

Savient Pharmaceuticals Inc’s experimental gout drug is safe and effective for certain patients with the debilitating joint disorder and should be approved, a U.S. advisory panel recommended on Tuesday.

The company is seeking Food and Drug Administration approval for the infused drug, called Krystexxa, for those who have the painful type of arthritis, but fail to get better with other treatments or cannot take other options for various reasons.

FDA’s panel of outside experts, in a 14-1 vote, said the dramatic results in nearly half of the patients studied were encouraging, despite risks that could include serious heart problems, including sudden death, and allergic reactions.

The agency will weigh the recommendation before making its final decision.

Krystexxa, known generically as pegloticase, could be a key product for the specialty biotech firm, which has just one other product on the U.S. market.

Investors have been eyeing the drug’s progress and shares of Savient soared more than 50 percent on Friday when related agency documents were released ahead of the panel meeting. Its shares were halted ahead of the committee’s vote after closing at $9.27 on the Nasdaq on Monday.

SILVER SPRING, Md.(Reuters)