On Friday, analysts’ bleak assessment of Amgen’s cardio data for its LDL fighter Repatha caught Esperion’s shares in a broad attack that afflicted several companies focused on cholesterol. But this morning the biotech’s stock bounded back, and then some, as the company announced that the FDA is willing to sign off on an approval for its lead drug — provided it clears LDL lowering goals in a pivotal study — without a cardio study as a prerequisite.
Esperion’s roller coaster ride got started last summer when shares plunged as the company raised the possibility that the FDA might demand the company complete a cardio outcomes trial before making a decision on marketing. This morning, though, they noted that the FDA is ready to use its LDL lowering data as sufficient to support an approval.
Starting with the caveat that biotechs aren’t always the best at reading what the FDA has to say to them — a problem that Amicus experienced recently — Esperion believes it will be ready to read out top-line results in the middle of next year.
An application could follow in the first half of 2019.
Esperion’s shares $ESPR soared more than 50% on the news.
Analysts have been watching this program closely, looking for a pill that could fit neatly between cheap statins and the $14,000 PCSK9 drug Repatha, which competes with Praluent for the statin-resistant market. Amgen trotted out positive cardio data on Friday, but analysts were left unimpressed by a drug that did not cut mortality rates, even though it did reduce the number of heart attacks.
Cue a slate of attacks focused on the Repatha trial design, which many felt was too short to find the kind of cardio data that would stop payers from setting up complex hurdles to prevent members’ access to the drug.
For Esperion to be successful, it would need to lower LDL sharply with its pill, which would position nicely against an injectable. And it would also need to sell it for significantly less.
Esperion’s on track to deliver its PCSK9 rival in the near future — if the FDA stays supportive.
Says Esperion CEO Tim Mayleben:
Our experienced lipid management team has worked closely with regulatory authorities and our key advisors to achieve this encouraging outcome. We continue to believe that bempedoic acid has the potential to provide physicians with a complementary and convenient oral treatment option that’s cost-effective for their patients with hypercholesterolemia who require additional LDL-C lowering. We remain focused on completing the global pivotal Phase 3 program for bempedoic acid and reporting top-line results from our long-term safety and tolerability study by Q2 2018 and top-line results from our ongoing Phase 3 LDL-C lowering efficacy studies by mid-2018.
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