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FDA grants fast track designation to SB-525 for hemophilia A

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The FDA granted fast track designation to SB-525 for the treatment of hemophilia A, according to the agent’s manufacturer.

SB-525 (Sangamo Therapeutics) — a complementary DNA gene therapy — uses an adeno-associated virus that carries a clotting Factor VIII gene construct.

The therapeutic’s high potency may allow clinically relevant levels of Factor VIII protein to be obtained using lower vector doses, according to a company-issued press release.

A phase 1/phase 2 clinical trial designed to evaluate SB-525 in adults with hemophilia A is expected to begin this year.

The FDA granted orphan drug designation to SB-525 earlier this month. That designation also applies to its use as treatment for hemophilia A.