FDA advisory panel recommends Savient’s gout drug – Krystexxa - for approval
Savient Pharmaceuticals

In a 14-1 vote, a US advisory panel of arthritis experts Tuesday recommended Savient Pharmaceuticals Inc's experimental gout drug - Krystexxa - for approval by the Food and Drug Administration.

The FDA's final decision on Savient's Krystexxa drug is likely to come by the end of July.

In its recommendation of the drug, the panel said that the infused drug is 'safe and effective' for treatment of certain patients with the debilitating joint disorder - in spite of some reported cases of heart problems associated with the drug's use - and should be approved.

Though before establishing the safety of the drug, FDA drug reviewers noted higher rates of heart problems linked to the use of the drug, against patients taking placebo, the panelists said the data did not definitively confirm the risk factor.

The East Brunswick, New Jersey-based Savient's Krystexxa drug is recommended for those patients suffering from painful type of arthritis who neither show any improvement with other treatments nor can take the alternatives for a number of reasons.

In support of the drug, which may be a key product for the specialty biotech firm, Savient officials said that patients who had benefited from Krystexxa - generically called pegloticase - saw 'quick, dramatic improvement,' with their swollen cyst-like lesions disappearing "at light speed"; and urged the panelists to support the drug.

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