FDA Approved OGSIVEO as the FIRST and ONLY treatment for Desmoid Tumours

The U.S Food and Drug Administration (FDA) approved OGSIVEO (nirogacestat) for the treatment of progressive desmoid tumors in adults who require systemic treatment.

OGSIVEO is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.

OGSIVEO is a first-in-class medication developed by SPRINGWORKS THERAPEUTICS INC.

OGSIVEO granted a Priority Review, FDA Fast Track and Breakthrough Therapy designations for the subject indication by the agency.

OGSIVEO granted ORPHAN designations status for desmoid tumors in the U.S. and will be eligible for seven years of exclusivity from approval date.

The medication will be available in SKU of 180 tablets of 50mg strength and packaged in a high-density polyethylene (HDPE) bottle with child-resistant closures.

The medicine will be commercially available in U.S. within five to ten business days.

Please refer the approval letter and approved label from FDA for further reading.