As reported on the Manila Times, Aucta Pharmaceuticals has officially introduced PYQUVI™ (deflazacort) oral suspension 22.75 mg/mL, marking the company’s entry into the U.S. commercial branded‑generic market. The therapy, released in late January 2026, is approved for patients aged 5 years and older with Duchenne muscular dystrophy (DMD) and is formulated to be bioequivalent to the reference product Emflaza®.
PYQUVI will be distributed solely through a specialty pharmacy, a channel the company says may better support families seeking streamlined access to deflazacort. DMD patients often encounter treatment delays related to insurance requirements and evolving clinical standards, challenges that Aucta hopes to mitigate through its planned patient support offerings.
Dr. Marie Tan, Associate Director of Medical Affairs, Clinical Operations, and Pharmacovigilance at Aucta Pharmaceuticals, noted that families affected by DMD routinely face administrative barriers that can complicate timely treatment. As part of the product rollout, the company intends to provide services centered on specialty pharmacy coordination and access assistance for eligible individuals.
The PYQUVI launch also sets the stage for Aucta’s next branded generic: ZELVYSIA™ (sapropterin dihydrochloride) Powder for Oral Solution. Scheduled for release in March 2026, ZELVYSIA is designed to help lower blood phenylalanine levels in patients with tetrahydrobiopterin‑responsive phenylketonuria (PKU) beginning at one month of age, in combination with a phenylalanine‑restricted diet.
Together, PYQUVI and the upcoming ZELVYSIA introduction highlight Aucta Pharmaceuticals’ expanding focus on treatments for rare diseases and its commitment to broadening access for affected patient communities.
Emflaza® is a registered trademark of PTC Therapeutics, Inc.
