Esperion Therapeutics has announced the FDA 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 plans to initiate the Phase III 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," said Tim M. Mayleben, president and Chief Executive Officer of Esperion. "We look forward to continuing our discussions with the FDA at next month's End-of-Phase II meeting as we advance ETC-1002 through the final phase of development."
