Esperion Says FDA Stance Means No Clear Regulatory Path For ETC-1002

Esperion Therapeutics and the FDA have failed to reach agreement on a definitive approval path for the company's cholesterol drug ETC-1002, raising the possibility of a long and more expensive development pathway for the oral therapy.

Barrier

Esperion Therapeutics Inc. had been working with the FDA in an attempt to forge a new regulatory path for its cholesterol drug ETC-1002 in statin-intolerant patients, a population the US agency has been very cautious about in the past.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

More from Scrip