Savient Pharmaceuticals says it's on track to resubmit its closely-watched gout drug for FDA marketing approval by the early part of 2010 after the FDA made it clear in a recent meeting that the developer will not need to mount any new clinical trials. And Savient says the resubmission could take six more months for regulators to review.
Last July, the agency had rejected Savient's request for an approval of Krystexxa, a new, second-line drug for chronic gout, after citing "deficiencies with the chemistry, manufacturing and controls" in its BLA. But now that the company has reverted to its original manufacturing process, no new trials will be needed as long as the final product matches the drug used in late-stage testing. The agency also outlined what the manufacturer, Bio-Technology General, has to do to resolve the agency's observations made during a pre-approval inspection.
Savient shares have been on a roller coaster ride throughout this year, with investors pushing its stock up and down with every new regulatory twist for the gout drug. Today, Savient shares jumped seven percent on the news.
- check out the Savient release
- here's the Reuter's piece