- Teva Pharmaceutical said Tuesday the FDA had rejected its application for a Huntington disease drug, indicating it had received a complete response letter from the regulator.
- The FDA asked Teva to examine "blood levels of certain metabolites" but will not require the generics maker to conduct new clinical trials for the drug, known as deutetrabenazine.
- Teva indicated it would resubmit an application for approval sometime in the third quarter of this year.
Huntington disease is a rare neurodegenerative disease caused by a faulty gene on chromosome 4, which leads to damaged nerve cells in the basal ganglia, cerebral cortex, and other parts of the brain. While it is similar to Parkinson's disease in certain ways, the damage to nerve cells occurs in a different part of the brain in Parkinson's patients.
Although Huntington and Parkinson's are different neurodegenerative disorders, both conditions result in movement-related disorders. Ninety percent of patients with Huntington eventually develop a movement disorder known as chorea, which Teva aimed to treat with deutetrabenazine.
Teva said the metabolites noted by the FDA are not novel and are also seen in patients who take other, already-approved drugs.
"We know that many people in the [Huntington disease] community are waiting for this new medicine. We understand there are very limited treatment options for [Huntington disease] patients and their families, hence we are accelerating the re-analysis process we were asked to conduct," said Michael Hayden, chief scientific officer at Teva.
While the FDA's decision might only delay the drug by a number of months, the FDA's initial rejection still represents a setback to Teva's plans. Teva had paid $3.2 billion to acquire Auspex Pharma and gain access to the drug, along with other central nervous system assets, notes The Wall Street Journal.
Teva is also investigating deutetrabenazine for the treatment of tardive dyskinesia and tics associated with Tourette syndrome.