Esperion Therapeutics Says FDA Removes 240 Mg Partial Clinical Hold On ETC-1002

(RTTNews) - Esperion Therapeutics Inc. (ESPR) said Tuesday that the U.S. Food and Drug Administration has removed the 240 mg partial clinical hold on ETC-1002 (bempedoic acid). This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies.

Esperion noted that it plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.

"We are pleased to receive a positive and rapid response from the FDA following our submission in early June of a complete response to the 240 mg partial clinical hold. We look forward to continuing our discussions with the FDA at next month's End-of-Phase 2 meeting as we advance ETC-1002 through the final phase of development," said Tim Mayleben, president and chief executive officer of Esperion.