Tim Mayleben on regulatory timeline
From Esperion CEO on safety of new cholesterol drug · · CNBCTelevision
“FDA approval is expected — this could hit the market in 2020.”
On , Tim Mayleben, Former CEO at Esperion Therapeutics, spoke about regulatory timeline during Esperion CEO on safety of new cholesterol drug on CNBCTelevision.
About Tim Mayleben
In October 2018, Tim Mayleben, then CEO of Esperion Therapeutics, discussed the company's experimental cholesterol drug bempedoic acid on CNBC. He stated that the drug is an oral, once-daily pill that demonstrated a reduction in LDL cholesterol by about 20% on top of statins and was safe and well tolerated. Mayleben said the drug is intended for patients taking the maximum tolerated dose of a statin who still need additional LDL lowering, including those who have had cardiac events. He noted that the drug did not appear to cause the same muscle aches associated with statins. Mayleben also said that in clinical studies involving roughly 4,000 patients, the drug's safety profile looked comparable to a placebo. He expected FDA approval and a market launch in 2020. Regarding business strategy, Mayleben said the company was open to a worldwide or regional partner for commercialization, as well as other strategic considerations, with the goal of benefiting shareholders. He added that his own wife, who has genetic cholesterol issues and cannot take statins, would be a candidate for the drug.