SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat, a scientific-minded, global clinical research organization (CRO), today congratulated Origin Biosciences for their FDA approval of Nulibry (fosdenopterin) for injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. This rare disease product received FDA approval on Friday, 26 February 2021, during the week when the world celebrated #RareDiseaseDay2021.
Veristat’s biostatisticians, programmers, and medical writers collaborated with Origin Biosciences to support the New Drug Application (NDA) for Nulibry. The entire Veristat team is honored to know that the hard work and perseverance of the combined Origin/Veristat team brought new hope for children whose lives are shortened by the devastating disease MoCD Type A.
“We thank the entire Veristat team who worked diligently to help us bring this critical therapy to patients with no other FDA-approved treatment options,” said Dr. Liza Squires, Origin Chief Medical Officer.
“Knowing that our work makes a difference in the lives of patients and their families around the world is the driving force of Veristat,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “Origin Biosciences offers hope to pediatric patients and their families who now have a first-of-its-kind therapy to extend life. I congratulate and thank everyone involved in this momentous achievement of bringing Nulibry to market. I cannot think of a better way to celebrate and culminate the week of Rare Disease Day 2021.”
Helping clients to commercialize more treatments for rare diseases is an evergreen goal at Veristat. We understand that nothing is standard when developing a therapy for a rare or ultra-rare disease. Every step of the clinical development and approval process is more complicated. That is why we have assembled a scientific-minded team of experts who have supported nearly 600 clinical programs and prepared more than 70 marketing applications for rare disease treatments and cures.
Veristat, a global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years’ experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last 10 years.
Veristat's focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. We apply this knowledge base every day to solve any clinical program's challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives. For more information, visit www.veristat.com.