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.
Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.Free Subscription