FDA News

FDA grants fast track status to anticoagulant reversal agent PER977

The FDA granted fast track status to PER977, an investigational anticoagulant reversal agent, according to a press release from the drug’s manufacturer.

PER977 (Perosphere) — a small synthetic water-soluble new molecular entity — directly combines with new oral anticoagulants, fondaparinux, low molecular weight heparins and unfractionated heparins to allow rapid re-establishment of a normal blood coagulation state through a reversal effect. This effect occurs due to direct binding to the anticoagulant molecule without binding to blood coagulation factors or to other proteins in the blood, according to the release.

PER977 is currently in clinical development as a sterile, IV injection.

"We are pleased that the FDA has granted Fast Track status for PER977 at this opportune time,” Solomon S. Steiner, PhD, chief executive officer of Perosphere, said in a press release. “We are currently preparing for phase 3 trials and expedited FDA guidance will facilitate optimal design and execution of our pivotal trials."

The FDA granted fast track status to PER977, an investigational anticoagulant reversal agent, according to a press release from the drug’s manufacturer.

PER977 (Perosphere) — a small synthetic water-soluble new molecular entity — directly combines with new oral anticoagulants, fondaparinux, low molecular weight heparins and unfractionated heparins to allow rapid re-establishment of a normal blood coagulation state through a reversal effect. This effect occurs due to direct binding to the anticoagulant molecule without binding to blood coagulation factors or to other proteins in the blood, according to the release.

PER977 is currently in clinical development as a sterile, IV injection.

"We are pleased that the FDA has granted Fast Track status for PER977 at this opportune time,” Solomon S. Steiner, PhD, chief executive officer of Perosphere, said in a press release. “We are currently preparing for phase 3 trials and expedited FDA guidance will facilitate optimal design and execution of our pivotal trials."

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