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www.fdanews.com/articles/82644-rapamycin-analog-granted-orphan-drug-status-in-eu

RAPAMYCIN ANALOG GRANTED ORPHAN-DRUG STATUS IN EU

November 22, 2005

The European Medicines Evaluation Agency has granted orphan-drug status for a non-prodrug rapamycin analog (AP23573 injection) for the treatment of soft-tissue and bone sarcomas.

The small-molecule drug potently inhibits the molecular target of rapamycin (mTOR), a critical downstream effector of the phosphatidylinositol 3-kinase (PI3K)/Akt (protein kinase B) signaling pathway, thereby inhibiting cell cycle progression, cell growth, and proliferation.