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Esperion Therapeutics (ESPR) - Get Esperion Therapeutics, Inc. Report and the U.S. Food and Drug Administration failed to reach agreement on a definitive approval path for the company's cholesterol-lowering pill, sending shares down 27% in Tuesday's after-market trading session.

The impasse centers around the need for a cardiovascular outcomes study to determine the benefit of treatment with Esperion's ETC-1002. The company wants to move quickly so it proposed a plan to conduct a phase III study using LDL-C lowering as a surrogate, but still approvable, efficacy endpoint. The large cardiovascular outcomes study would still be conducted to confirm ETC-1002's benefit, but after the drug secures U.S. approval.

FDA officials would not sign off on Esperion's plan, raising the possibility of an extra-long development pathway for ETC-1002.

In a statement issued Tuesday after meeting with the FDA, Esperion said the agency "did not provide clarity on a regulatory pathway for an LDL-C lowering indication in the U.S. in statin intolerant patients at this time."

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Esperion added that FDA wanted flexibility to change its mind on an approval standard for ETC-1002 depending on potential changes in the standard of care.

If LDL-C cannot be used as a surrogate endpoint for approval, Esperion would have to conduct the cardiovascular outcomes trial before submitting ETC-1002 for approval. This would delay the approval submission to 2022, the company said.

Esperion expects to end the year with $220 million in cash, enough to fund operations into 2019, including the phase III studies using LDL-C as the efficacy endpoint. The company would have to raise additional money to complete a cardiovascular outcomes study.

Esperion shares fell 27% to $11.75 in Tuesday night trading. 

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.