X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    $2 Million Gene Therapy Might Become The Standard In The US

    $2 Million Gene Therapy Might Become The Standard In The US

    Cancer Medicine Prices Jump 53% In Five Years In The U.S

    Food And Drug Administration User Fee Has Been Reauthorized

    Cancer Clinical Trials Get A Brand New Platform In Melbourne

    Report Indicates UK £62bn Behind In Global R&D Investment

    Wall Street Cautiously Optimistic After Gene Therapy Deals

    RoboCap: A Robotic Capsule to Improve Gut Drug Delivery

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    $2 Million Gene Therapy Might Become The Standard In The US

    $2 Million Gene Therapy Might Become The Standard In The US

    Cancer Medicine Prices Jump 53% In Five Years In The U.S

    Food And Drug Administration User Fee Has Been Reauthorized

    Cancer Clinical Trials Get A Brand New Platform In Melbourne

    Report Indicates UK £62bn Behind In Global R&D Investment

    Wall Street Cautiously Optimistic After Gene Therapy Deals

    RoboCap: A Robotic Capsule to Improve Gut Drug Delivery

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development FDA Approvals

AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix

Yuvraj_pawp by Yuvraj_pawp
27th October 2017
in FDA Approvals, News

AbbVie , a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc.announced that the U.S. FDA has granted priority review for elagolix, an investigational, orally administered GnRH antagonist, being investigated for the management of endometriosis with associated pain.

The FDA grants priority review to medicines that it determines have potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease1. AbbVie expects the Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review will be in Q2 2018.

“We are pleased that elagolix has been granted priority review by the FDA and will continue to work closely with the agency to hopefully bring this treatment to women suffering from endometriosis as soon as possible,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

The NDA is supported by data from the largest prospective randomized clinical trials conducted to date for endometriosis. The safety and efficacy of elagolix were evaluated in nearly 1,700 women with moderate-to-severe endometriosis-associated pain.

About Elagolix
Elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, is an orally administered, short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in readily reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the ovarian sex hormones, estradiol and progesterone, while on therapy. Elagolix is currently being investigated in diseases that are mediated by ovarian sex hormones, such as uterine fibroids and endometriosis. To date, elagolix has been studied in over 40 clinical trials totaling more than 3,000 subjects. The FDA granted priority review for AbbVie’s NDA for endometriosis in Q4 2017. Phase 3 trials of elagolix for the management of uterine fibroids are ongoing.

About Endometriosis
Endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside of the uterus, leading to long-term pelvic pain (during or between periods), pain with intercourse and other painful symptoms.2 These growths are called lesions and can occur on the ovaries, the fallopian tubes, or other areas near the uterus, such as the bowel or bladder.2,3 Estrogen fuels the growth of lesions.3 There is no cure for endometriosis,4 and the associated pain is currently managed with oral contraceptives, progestins, danazol, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH agonists, many of which are not specifically indicated for the treatment of endometriosis.3 In more extensive cases, surgical interventions (e.g., laparotomy or laparoscopy) are often pursued, and may not be curative for all individuals.5

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com

Media

Toni Haubert
antoinette.haubert@abbvie.com
(847) 936-5382

Investors
Liz Shea
liz.shea@abbvie.com
(847) 935-2211

Tags: America
Previous Post

Irvine Scientific Will Now Offer Sunlight Medical Pipettes in the United States

Next Post

Eagle Pharmaceuticals Receives Tentative FDA Approval for PEMFEXY (Pemetrexed Injection) Ready-to-Dilute

Related Posts

Clinical Trials

Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

8th November 2022
Facilities & Operation

India Seeks Better Pharma Market Access In The UK: Official

8th November 2022
First Virtual Drug Study Tests 2 Likely Alzheimer Therapies
Clinical Trials

First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

7th November 2022
Facilities & Operation

CPhI Pharma Index Shows Unprecedented Global Pharma Optimism

5th November 2022
$2 Million Gene Therapy Might Become The Standard In The US
Drug Development

$2 Million Gene Therapy Might Become The Standard In The US

5th November 2022
News

Cancer Medicine Prices Jump 53% In Five Years In The U.S

3rd November 2022
Next Post

Eagle Pharmaceuticals Receives Tentative FDA Approval for PEMFEXY (Pemetrexed Injection) Ready-to-Dilute

Latest News

Clinical Trials

Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

8th November 2022
Facilities & Operation

India Seeks Better Pharma Market Access In The UK: Official

8th November 2022
First Virtual Drug Study Tests 2 Likely Alzheimer Therapies
Clinical Trials

First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

7th November 2022
Facilities & Operation

CPhI Pharma Index Shows Unprecedented Global Pharma Optimism

5th November 2022
$2 Million Gene Therapy Might Become The Standard In The US
Drug Development

$2 Million Gene Therapy Might Become The Standard In The US

5th November 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In