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La Jolla’s Giapreza: Emergency Use Requests Sped US FDA Approval For Septic Shock

 
• By Sue Sutter

After publication of ATHOS-3 study results, agency received several requests from medical community for emergency use in hospitalized patients with shock and hypotension unresponsive to available therapy, spurring FDA to take an approval action two months ahead of user fee goal date.

Drug Review Profile regular column

An influx of emergency use requests for La Jolla Pharmaceutical Co.'s Giapreza (angiotensin II) following publication of positive Phase III results spurred the US FDA to expedite approval of the septic shock treatment more than two months ahead of the drug's user fee deadline.

FDA approved Giapreza (formerly known as LJPC-501) to increase blood pressure in adults with septic or other distributive shock on...

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