Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) announced Wednesday the acceptance of its New Drug Application for a new Huntington disease medication by the US Food and Drug Administration. The SD-809 was approved for the treatment of chorea associated with the disease, a fatal disorder affecting fewer than 200,000 people in the US.
Teva CSO Michael Hayden said, "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."
The Israeli pharmaceutical giant added SD-809 to its portfolio with the $3.2 billion acquisition of Auspex back in May. The drug had been granted Orphan Drug Designation by the FDA six months earlier, in November 2014.
A source familiar with the industry expects the FDA to respond to Teva's application within a year.
"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," added Hayden.
Huntington disease, passed genetically, affects five to seven people per 100,000 in Western countries, according to the World Health Organization.
Teva Global Specialty Medicines president Rob Koremans said, "Teva plans to commercialize SD-809 in the US by drawing from vast experience in facilitating therapy initiation and patient support in other disease areas. 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 company chose to file the NDA after seeing positive results from two Phase-III studies, including the ARCH-HD trial which demonstrated that patients were able to successfully convert overnight to SD-809 from the only drug approved for treatment.
Published by Globes [online], Israel business news - www.globes-online.com - on August 12, 2015
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