Drug Development

Esperion tanks on warning that the road to an FDA decision could be much, much longer than they thought

Last summer Esperion ($ESPR) triggered a big rally for its shares when CEO Tim Mayleben told investors and analysts that the FDA wouldn’t require a longterm cardio outcomes study before issuing a marketing decision on its cholesterol-lowering drug.

Today, that one-time certainty became distinctly cloudy as Mayleben says the FDA may in fact do what some investors had feared — put any marketing decision well down the road.

The Ann Arbor-based biotech’s stock tanked, plunging 27% in after-market trading.

Mayleben saved the bad news for last in his statement, starting off with encouraging word that his marketing application for bempedoic acid (ETC-1002) is on track in Europe, where the regulatory path should be clearly defined. However….

“However,” the company stated, “the FDA 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. The Agency indicated its position regarding an LDL-C lowering indication could be impacted by potential future changes in their view of LDL-C lowering as a surrogate endpoint or the possibility of a shift in the future standard-of-care for statin intolerant patients with elevated LDL-C levels. In the event LDL-C lowering is no longer a surrogate endpoint for initial approval in the future, Esperion would plan to submit a New Drug Application to FDA for a CV disease risk reduction indication on the basis of a successful completion of the CVOT, which would include the results of the LDL-C lowering efficacy studies, by 2022.”

In translation: A changing regulatory environment could put off any potential approval in the world’s biggest market by years.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 30,600+ biopharma pros who read Endpoints News by email every day.

Free Subscription


Director/Sr Director, Oncology/Immuno-Oncology
Aro Biotherapeutics Company Denver, CO
Director/Sr. Director Oncology
Aro BioTx Philadelphia, PA
Manufacturing Associate – Upstream
Molecular Templates Austin, TX
Scientist, Process Development
Molecular Templates Austin, TX
GMP Supervisor - Downstream
Molecular Templates Austin, TX
Quality Control (QC) Associate
Molecular Templates Austin, TX

Visit Endpoints Careers ->