#United States #Basking Ridge #Duchenne Muscular Dystrophy #Aucta Pharmaceuticals #PYQUVI

Aucta Pharmaceuticals Set to Launch PYQUVI™

Aucta Pharmaceuticals, Inc. is gearing up for the introduction of PYQUVI™, an oral suspension containing deflazacort, set to launch in late January 2026. This product signifies a groundbreaking addition to Aucta's portfolio, marking its first commercial branded-generic treatment in the United States.

PYQUVI, presented as a 22.75 mg/mL oral suspension, is specifically aimed at treating patients aged five and older suffering from Duchenne muscular dystrophy (DMD). This condition is a challenging and progressive muscle disease that predominantly affects boys, leading to severe physical disabilities as the individual ages. The aim of introducing PYQUVI is to provide an accessible therapeutic option for those experiencing this debilitating disease, with the formulation designed to be bioequivalent to existing treatments such as Emflaza® (deflazacort) oral suspension.

The approach adopted by Aucta is strategic, highlighting both medical efficacy and patient convenience. According to Dr. Marie Tan, the Associate Director of Medical Affairs at Aucta, individuals living with DMD and their families frequently contend with numerous challenges related to treatment access, including complexities in insurance coverage and shifting standards in clinical care. These hurdles can significantly impede the timely availability of essential medication, exacerbating the daily struggles faced by patients.

In response, Aucta Pharmaceuticals plans not only to launch PYQUVI but also to implement a patient support program that focuses on enhancing access to the medication through specialty pharmacy channels. This initiative is poised to alleviate some of the logistical burdens that families dealing with DMD face, ultimately improving their treatment experience.

In addition to PYQUVI, Aucta Pharmaceuticals is also preparing to unveil another product, ZELVYSIA™, a powder for oral solution containing sapropterin dihydrochloride. Expected to launch in March 2026, shortly after PYQUVI, ZELVYSIA is geared towards reducing blood phenylalanine levels for patients diagnosed with hyperphenylalaninemia, a metabolic condition often associated with phenylketonuria (PKU). Together, these launches demonstrate Aucta's commitment to expanding its branded generic offerings, specifically within rare diseases, reinforcing its mission to fulfill unmet medical needs.

Both products are pivotal for the communities affected by these conditions, facilitating better management options and potentially leading to enhanced quality of life. As Aucta pharmaceuticals takes this significant step, it highlights the company’s dedication to pioneering treatment pathways that support individuals facing rare diseases.

Important Safety Information

PYQUVI is a corticosteroid with specific contraindications and warnings, including the potential for serious endocrine alterations and increased risk of infections, making patient monitoring crucial during treatment. Similarly, ZELVYSIA carries its own set of safety information and precautions. Patients and caregivers are advised to consult the prescribing information for both medications to understand the full spectrum of prescriptions and guidelines.

As the launch date approaches, Aucta Pharmaceuticals is poised to make a significant impact in the realm of rare disease treatments, reinforcing its commitment to providing innovative solutions that enhance patient care. For more information, patients and healthcare providers can refer to Aucta’s official website or contact the company directly for further inquiries.