Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases, owned by Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), today announced the continued availability of NULIBRY (fosdenopterin) for Injection and the launch of Sentynl Cares.
|
SOLANA BEACH, Calif., April 25, 2022 /PRNewswire/ -- Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases, owned by Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), today announced the continued availability of NULIBRY (fosdenopterin) for Injection and the launch of Sentynl Cares. NULIBRY is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening pediatric genetic disorder. Sentynl Cares provides a comprehensive set of support programs dedicated to helping children with MoCD Type A in the United States gain access to NULIBRY. Sentynl Therapeutics Announces Continued Availability of NULIBRY® (fosdenopterin) and Launch of Sentynl Cares™ Program.
Recognizing that most patients with MoCD Type A experience delayed or missed diagnoses that may affect patient outcomes, Sentynl plans to advance initiatives aimed at providing an earlier diagnosis and treatment of the disease. These initiatives include:
Sentynl's Chief Executive Officer, Matthew Heck, said, "Early diagnosis and therapeutic intervention is critical to MoCD Type A disease patients and their caregivers. Our company is proud to advance initiatives that are aimed at earlier diagnosis and treatment of rare diseases like MoCD Type A." Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., said, "These initiatives align with our core purpose to empower patients suffering from rare disease with the freedom to live healthier and fulfilled lives. Zydus is proud that NULIBRY (fosdenopterin) is now among its portfolio of rare disease treatments designed improve outcomes for patients and their caregivers." About Molybdenum Cofactor Deficiency (MoCD) Type A MoCD Type A is an ultra-rare disease. The incidence and prevalence of MoCD Type A in the United States are not known, but the estimated incidence is 1 per 100,000 live births.3 Based on these estimates, MoCD Type A is likely to be underdiagnosed, with an estimated 22 to 26 missed diagnoses per year in the United States and European Union. The most common presenting symptoms of MoCD Type A are seizures, feeding difficulties and encephalopathy. Patients with MoCD Type A who survive beyond infancy typically suffer from progressive brain damage, which presents in characteristic patterns on magnetic resonance imaging (MRI). This damage leads to severe psychomotor impairment and an inability to make coordinated movements or communicate with their environment. About NULIBRY (Fosdenopterin) for Injection INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Potential for Photosensitivity NULIBRY can make the patient oversensitive to sunlight. NULIBRY-treated patients or their caregivers are advised to avoid or minimize patient exposure to sunlight and artificial UV light and adopt precautionary measures when exposed to the sun, including wearing protective clothing and sunglasses, and use broad-spectrum sunscreen with high SPF in patients 6 months of age and older. If photosensitivity occurs, caregivers/patients are advised to seek medical attention immediately and consider a dermatological evaluation. ADVERSE REACTIONS The most common adverse reactions in NULIBRY-treated patients were infusion catheter–related complications (89%), pyrexia (fever) (78%), viral infection (56%), pneumonia (44%), otitis media (ear infection) (44%), vomiting (44%), and cough/sneezing (44%). Adverse reactions for rcPMP-treated patients were similar to the NULIBRY-treated patients. PATIENT COUNSELING INFORMATION Please read the FDA-approved NULIBRY Prescribing Information and Instructions for Use and follow the instructions on how to prepare and administer NULIBRY. NULIBRY has a potential for photosensitivity; see Warnings and Precautions. Seek medical attention immediately if the patient develops a rash or if they notice symptoms of photosensitivity reactions (redness, burning sensation of the skin, blisters). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. About Sentynl Cares: Sentynl Cares is a comprehensive set of support programs dedicated to helping children get access to our therapies. Sentynl Cares also provides tools and resources to help facilitate the access process. References About Sentynl Therapeutics About Zydus Sentynl Therapeutics Contact:
SOURCE Sentynl Therapeutics |
View original content:
