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Genentech's TPA Faced Tougher Test Before FDA

WASHINGTON—False assumptions, deficient data, lack of guidelines and a bureaucratic handoff all figured in a federal advisory panel's decision last month not to recommend approval of tissue plasminogen activator (TPA), widely touted as biotechnology's first "blockbuster" drug. The Food and Drug Administration (FDA) panel's action stunned Genentech Inc., the South San Francisco company that had hoped to begin marketing the blood clot-dissolving drug this summer. The company said it hopes to

Dawn Bennett
WASHINGTON—False assumptions, deficient data, lack of guidelines and a bureaucratic handoff all figured in a federal advisory panel's decision last month not to recommend approval of tissue plasminogen activator (TPA), widely touted as biotechnology's first "blockbuster" drug.

The Food and Drug Administration (FDA) panel's action stunned Genentech Inc., the South San Francisco company that had hoped to begin marketing the blood clot-dissolving drug this summer. The company said it hopes to satisfy the panel's objections within, eight months, but some biotech industry analysts say the decision has set back Genentech's efforts by more than a year, providing an opportunity for competitors to catch up.

The FDA advisory panel said May 29 that, although Genentech had provided adequate data showing that TPA dissolves blood clots, its studies did not show that the drug prolongs patients' lives or protects their cardiovascular function. Earlier that day, the panel had recommended approval for intravenous...

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