Esperion confirms FDA acceptance of two NDAs for regulatory review
Category: #health  By Mateen Dalal  Date: 2019-05-06
  • share
  • Twitter
  • Facebook
  • LinkedIn

Esperion confirms FDA acceptance of two NDAs for regulatory review

The NDAs are for oral therapies developed as medication for patients with raised LDL-C who require additional LDL-C lowering

Esperion has recently announced that the U.S. Food and Drug Administration has officially accepted both bempedoic acid & bempedoic acid/ezetimibe combination tablet New Drug Applications for filing as well as regulatory review.

Apparently, the bempedoic acid and bempedoic acid-ezetimibe combination tablet have been developed as affordable, suitable, once-daily, complementary, oral therapies for the medication of patients with raised low-density lipoprotein cholesterol or LDL-C who require additional lowering of LDL-C in spite of using presently accessible therapies.

Sources mentioned that the Prescription Drug User Fee Act (PDUFA) goal date is set for 21 February 2020 for the completion of the NDA review of bempedoic acid. The PDUFA goal date for completing the NDA review of bempedoic acid/ezetimibe combination tablet is set for 26 February 2020.

Chief Executive Officer and President of Esperion, Tim M. Mayleben, confirmed that both New Drug Applications have been accepted for filing by the US FDA.

Mayleben said that the acceptances for regulatory review of these therapies confirm the superior-quality submissions and outstanding effort of the company’s Lipid Management Team, bringing the acid-based therapies of oral bempedoic further close to the patients and physicians who will benefit from them.

Seemingly, the worldwide LDL-C Phase 3 Lowering Program of Esperion has been undertaken to support EMA and FDA Submissions. The company completed its worldwide, pivotal, Phase 3 clinical development program as well as unveiled positive cumulative results previous year in October.

The program evaluated the consistency, safety and tolerability, complementary LDL-C-lowering efficiency of bempedoic acid/ezetimibe combination tablet and bempedoic acid in patients with ASCVD or who are at high risk for ASCVD.

Sources further mentioned that bempedoic acid/ezetimibe combination tablet and bempedoic acid are new medication applications are under supervisory review by FDA. The marketing authorization applications for these product applicants are also under regulatory review by European Medicines Agency.

Source Credit: https://www.nasdaq.com/press-release/esperion-announces-us-fda-acceptance-of-new-drug-applications-ndas-for-both-bempedoic-acid-and-the-20190505-00013

https://investor.esperion.com/news-releases/news-release-details/esperion-announces-us-fda-acceptance-new-drug-applications-ndas

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

Air France-KLM & JAL make bids to purchase stake in Malaysia Airlines
Air France-KLM & JAL make bids to purchase stake in Malaysia Airlines
By Mateen Dalal

Air France–KLM S.A., one of the leading global air transport players, has reportedly made a proposal to invest in Malaysia Airlines and gain around 49 percent stake. Japan Airlines (JAL) is also looking to acquire a 25 percent stake in Mal...

Accenture opens innovation center in South Beach Road office
Accenture opens innovation center in South Beach Road office
By Mateen Dalal

Accenture, an Irish multinational professional services company, has recently opened a global innovation center within the Accenture’s office at South Beach Road, which is supported by EDB (Economic Development Board) in Singapore. It will pro...

Verrica unveils positive data from VP-102 study in molluscum treatment
Verrica unveils positive data from VP-102 study in molluscum treatment
By Mateen Dalal

Findings from the study are being produced at the 17th Annual Winter Clinical Dermatology Conference in Kohala Coast The data indicated a considerable increase in the percentage of patients with lesion clearance in VP-102 group Verrica Pharmaceu...