Teva Pharmaceutical Industries Limited TEVA suffered a regulatory setback with the FDA issuing a complete response letter (CRL) for the new drug application for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD).
In its CRL, the FDA has asked Teva to re-analyze blood levels of certain metabolites. Teva noted that these metabolites are not novel and are also observed in patients taking tetrabenazine or deutetrabenazine. Importantly, the regulatory agency did not ask the company to conduct additional studies.
Teva plans to work closely with the FDA to address the issue. A response to the CRL will be submitted in the third quarter of 2016.
Although the CRL on SD-809 comes as a disappointment for Teva, the most important thing is that the FDA has not asked the company for additional studies to be conducted, which would have delayed the candidate from entering the U.S. markets further.
Per the company’s press release, HD is a rare and fatal neurodegenerative disorder affecting approximately one in 7,000–10,000 people in western countries. While chorea is one of the most prominent physical manifestations of this disease, it occurs in roughly 90% of patients at some point in the course of their illness.
Notably, SD-809 is the first deuterated product to be reviewed by the FDA. Considering the lack of treatments for HD, its approval will be a huge boost for the patient population as well as for the company.
We note that SD-809 became a part of Teva’s pipeline following the May 2015 acquisition of Auspex Pharmaceuticals.
Apart from HD, Teva is also evaluating SD-809 for a couple of additional indications including treatment of patients with tardive dyskinesia (TD) and Tourette syndrome (TS). Currently, a phase III (AIM-TD) efficacy and safety study in patients with moderate-to-severe TD is in progress with additional data from the study anticipated later in 2016. The company is also planning to evaluate SD-809 for the treatment of tics associated with TS.
Teva is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Retrophin, Inc. RTRX and Bristol-Myers Squibb Company BMY. All three stocks sport a Zacks Rank #1 (Strong Buy).
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