- The Food and Drug Administration on Thursday accepted Teva Pharmaceutical’s application for its drug aimed at treating chorea, a disorder often linked to Huntington’s disease. The FDA plans to make a decision on whether to accept or reject the company’s drug, SD-809 (deutetrabenazine), by April 3, 2017.
- The acceptance comes nearly five months after the FDA shot down Teva’s initial application, which the Jerusalem-based specialty pharma originally submitted in August 2015. In a Complete Response Letter, the agency requested more data on how the drug affected levels of non-novel metabolites in patients’ blood.
- Huntington’s disease is an illness that progressively erodes the brain’s nerve cells. Though no cure exists for the disease, it is frequently treated with drugs that block dopamine receptors. That treatment, however, can lead to the development of chorea, a disorder characterized by loss of muscle control.
Teva dropped a pretty penny, $3.2 billion of them actually, to acquire Auspex Pharmaceuticals and, by extension, the drug in May 2015. Understandably, it has a lot of incentive to see the drug approved.
"We are committed to continuing our collaboration with the FDA to make this potential treatment option available to patients," Teva’s Chief Scientific Officer Michael Hayden said an October 20 statement.
Teva has reported positive clinical results for its drug in treating tardive dyskinesia, another involuntary movement disorder closely related to chorea. The drug received orphan designation in late 2014, and the hope is that it will be effective at treating one of the most debilitating illnesses related to Huntington’s.
"There is a serious and growing medical need as tardive dyskinesia is one of the most debilitating and often irreversible side effects of dopamine receptor blocking agents, which are increasingly being used in the United States for various psychiatric disorders and gastrointestinal conditions," Hubert Fernandez, the principal investigator for the SD-809 study, said in a July 2015 Teva statement.
Teva shares increased 2% to $44.21 on Thursday, though it stock remains down nearly 33% year-to-date, as the specialty pharma scrambles to fill its pipeline and shore up several years of missteps.