Ascendis Pharma launches YUVIWEL in U.S. following orphan drug exclusivity award

Ascendis Pharma (NASDAQ:ASND) has officially commenced the commercial launch of YUVIWEL® (navepegritide) in the United States, marking the availability of the first once-weekly treatment for pediatric patients with achondroplasia.

The Copenhagen-based biopharmaceutical company announced on April 6, 2026, that the U.S. Food & Drug Administration (FDA) has granted YUVIWEL orphan drug exclusivity, a designation that provides the company with protected marketing rights through February 27, 2033.

The exclusivity follows the drug’s initial accelerated approval in February 2026 and acknowledges YUVIWEL as a differentiated treatment option for children aged two years and older with open epiphyses (growth plates).

YUVIWEL, developed using Ascendis' proprietary TransCon® technology, is a prodrug of C-type natriuretic peptide (CNP).

It is engineered to provide continuous systemic exposure to active CNP throughout the weekly dosing interval, counteracting the overactive signaling of the FGFR3 gene that characterizes achondroplasia—the most common form of skeletal dysplasia.

Commercial distribution is currently underway, with multiple prescriptions already approved for reimbursement for children enrolled through the Ascendis Signature Access Program® (A.S.A.P.).

This support initiative is designed to assist caregivers and patients with navigating the treatment journey, including financial assistance and prior authorization support.

The company confirmed that revenue recognition has begun following the initiation of therapy for the first wave of patients.