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 use of streptokinase, an older, less efficient clot-dissolving agent previously approved only for direct coronary artery injection in treating heart attack patients. Observers say Genentech's presentation suffered in comparison with the well-crafted studies adduced in support of ...
