Eight months after Teva scooped up the promising SD-809 (deutetrabenazine) to correct a severe movement disorder afflicting some 500,000 patients in the U.S., the company has scored bragging rights to the FDA's breakthrough drug designation.
The drug is already under FDA review for Huntington's disease, but Teva ($TEVA) sees some gains on the regulatory front as it plans to expand the use of the drug to other patient populations which suffer from tardive dyskinesia.
The drug is a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, which is designed to regulate the levels of dopamine in the brain. Teva acquired the drug and its developer in March, a few months after Auspex unveiled promising late-stage data on the drug. Auspex was valued at $3.2 billion in the deal. The FDA accepted the NDA for review in March.
Simply put, SD-809 is a deuterated version of tetrabenazine--Lundbeck's Xenazine, already in use for Huntington's--that is designed to break down more slowly in the body, allowing physicians to give it less often in lower doses for maximum efficacy.
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| Teva CSO Michael Hayden |
The FDA believes that new-and-improved profile is worthy of its BTD title, which Teva--hardly a top performer in R&D--will gladly take. Whatever impact the BTD may have on the regulatory side, there has been new research at Dartmouth that shows that using words like "breakthrough" in describing a new drug has a big impact on the way patients view a new drug. So it might help sales at Teva as much as anything.
"The granting of Breakthrough Therapy Designation by the FDA represents significant progress toward advancing the clinical program for SD-809, as a potential, much-needed treatment option for the underserved tardive dyskinesia patient population," said Michael Hayden, the CSO at Teva, in a statement. "We remain excited about studying this innovative compound across a number of indications."
- here's the release
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