The ODYSSEY continues for PCSK9s
- Sanofi and Regeneron Pharmaceuticals revealed Thursday morning the ODYSSEY cardiovascular outcomes trial will continue, despite a pre-specified interim analysis.
- An independent data monitoring committee (DMC) completed the analysis and signaled that the 18,000-patient study had not surpassed the efficacy thresholds required to stop the trial early.
- ODYSSEY, now expected to read out in 2017, is testing the cholesterol-lowering drug Praluent (alirocumab) to evaluate the drug's cardio-protective effects on high-risk CV patients, if any.
The PCSK9 class is going to have to wait a little longer for validation. The continuation of the ODYSSEY study isn't a major negative for the drug — these studies are only stopped in the event of a safety problem or overwhelming efficacy — but the market is probably a little disappointed to still not have any answers about the CV benefits of this closely-watched class of cholesterol drugs.
PCSK9 inhibitors were highly anticipated before reaching the market in the summer of 2015, but sales of both Praluent and Amgen's competing Repatha (evolocumab) have been non-starters, bringing in less than $90 million each through the first three quarters of 2016.
Part of the problem has been administration, PCSK9s are once-monthly injectables, while statins come in an easy-to-take pill. But pricing and access have also played a significant role in slowing uptake; these drugs cost significantly more than their generic counterparts and negotiations with payers haven't been favorable.
Successful conclusion of the ODYSSEY study could be a major boost on the efficacy front — payers and doctors are more likely to prescribe the drugs if they lower the risk of further CV events.
Amgen gave a preview at the American Heart Association meeting earlier this week when it announced the results from the 968-patient GLAGOV study. The percent change in LDL-C during treatment was -63.7%. Repatha was found to change atheroma volume, the primary endpoint, by -0.95% compared with placebo of +0.05%.
The trial is not an outcomes study — Amgen's FOURIER outcomes study isn't expected to report out until at least 2017 — but could be a positive read-through to FOURIER.
All of this could mean an opportunity for The Medicines Co. in 2017 as well, which is developing a PCSK9 synthesis inhibitor.
- Regeneron Statement
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