Teva Pharmaceutical Industries Limited — Austedo FDA Review (NDA208082, ORIG 1, 2017)
Teva Pharmaceutical Industries Limited · 2017 · FDA Review (openFDA) · company profile →
Report summary
The FDA review of Teva's Austedo (deutetrabenazine) for Huntington's Disease (NDA208082) spanned multiple cycles, initially raising concerns about uncharacterized metabolites (M1, M4) and product quality, leading to a Complete Response Letter. Efficacy in reducing chorea was consistently demonstrated in trials like C-15, with significant improvements in Total Maximal Chorea scores. Safety concerns included somnolence, depression, suicidality, akathisia, and parkinsonism, though no new REMS were deemed necessary. The second review cycle resolved clinical pharmacology questions regarding metabolites, confirming an acceptable safety profile and leading to a recommendation for approval. Post-marketing commitments include evaluating dependence, withdrawal, and rebound effects.
Key findings — cited to the page
| Irritability in Placebo arm (Trial C-15) | 13 % | Trial C-15 · p.33 |
| Irritability in SD-809 arm (Trial C-15) | 7 % | Trial C-15 · p.33 |
| Percentage of patients with Irritability AE in Study C-16 (open label SD-809) | 8.4 % | Study C-16 · p.244 |
| Irritability AE count in SD-809 arm of Study C-15 | 2 | Study C-15 · p.245 |
| Irritability AE count in Placebo arm of Study C-15 | 4 | Study C-15 · p.245 |
| Patients with Irritability AE in Study C-16 (open label SD-809) | 10 | Study C-16 · p.244 |
| Irritability (Total, Study 016) | 8 % | Study 016 · p.147 |
| AE counts for SD-809 arm in C-15 | 101 | Study C-15 · p.235 |
| IND Number | 112975 | · p.38 |
| Number of visits at Week 67 (Study C-16) | 94 | Study C-16 · p.15 |
| Complete Response Letter issuance date | May 27, 2016 | Austedo · p.8 |
| Orphan drug designation granted date | December 5, 2012 | Austedo (deutetrabenazine) · p.185 |
Source: Teva Pharmaceutical Industries Limited ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →