Table 2.
PCSK9 Inhibitors in Late-Stage Development
| Generic (trade) name/manufacturer | Clinical trials | Phase 3 clinical trial data available | FDA approval date | MAb type | Route | Dose |
|---|---|---|---|---|---|---|
| Alirocumab (Praluent) Sanofi-Aventis/Regeneron |
ODYSSEY series | Yes | Approved July 24, 2015 |
Fully human MAb | SC | 75 mg every 2 weeks or 150 mg every 4 weeks |
| Bococizumab (not available) Pfizer |
SPIRE series | No, phase 3, scheduled to be completed in 2015, 2016, and 2017 | Expected approval in 2017 | Humanized MAb | SC | 150 mg every 2 weeks or 300 mg every 28 days |
| Evolocumab (Repatha) Amgen |
OSLER PROFICIO; DESCARTES; MENDEL; GAUSS; RUTHERFORD; TESLA; FOURIER; LAPLACE, TAUSSIG, GLAGOV | Yes | Approved August 27, 2015 | Fully human MAb | SC | 140 mg every 2 weeks or 420 mg monthly |
FDA indicates US Food and Drug Administration; MAb, monoclonal antibody; SC, subcutaneous.