Teva Announces FDA Acceptance of NDA for SD-809 for Huntington Disease Treatment
News Aug 17, 2015
Teva Pharmaceutical Industries Ltd. has announced that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has been accepted by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington disease (HD), a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries, according to the World Health Organization.
“The opportunity to bring a new treatment option to those battling the devastating illness of Huntington disease is an important first step and an indication of our profound commitment to improving the lives of patients with this and other debilitating movement disorders,” saidMichael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “With this filing and an ongoing investment in HD research, Teva has further established itself as a leader in the development of treatments focusing on movement disorders.”
“Teva plans to commercialize SD-809 in the U.S. by drawing from vast experience in facilitating therapy initiation and patient support in other disease areas. Within Global Specialty Medicines, we have a rich history of demonstrating our commitment to the patient and bringing value to the neurology community,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “People living with neurodegenerative disorders and those around them often need support and services beyond medications. We intend to meet these needs with our proven infrastructure and our focus on the patient.”
The NDA filing is based on positive results from two Phase-III studies, FIRST-HD and ARC-HD. In the placebo-controlled, randomized FIRST-HD study, SD-809 reduced chorea in patients with HD. Positive top-line data from the Phase-III, open-label ARC-HD study demonstrated that patients were able to safely convert from tetrabenazine, currently the only approved HD treatment, to SD-809 overnight with continued control of chorea.
SD-809 was granted Orphan Drug Designation for the treatment of HD by the FDA inNovember 2014 and became part of Teva’s CNS portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.
3-D Tissue Model of Developing Heart Could Aid Drug Safety Testing for Pregnant WomenNews
Parents and doctors often have to consider the mother's health as well as the potential risk regarding how medication could affect their baby. Researchers have developed a process to make a 3D tissue model that could mimic early stage human heart development, which could aid drug safety testing and help determine a drug's effects on fetal development.READ MORE
Daily Dose of Viagra Could Reduce Colorectal Cancer RiskNews
A small, daily dose of Viagra significantly reduces colorectal cancer risk in an animal model that is genetically predetermined to have the third leading cause of cancer death, scientists report.READ MORE
Comments | 0 ADD COMMENT
World Congress on Advanced Pharmacy and Clinical Research
Jul 16 - Jul 17, 2018