The Institute for Clinical and Economic Review (ICER) recently released a draft evidence report assessing the clinical effectiveness and value of elagolix (ABT-620) for the management of endometriosis and associated pain.
The draft evidence report will be open to public comment until May 31. The findings reported in this document are preliminary and subject to change based on additional stakeholder input and further data analysis.
The therapeutic candidate is currently being reviewed by the U.S. Food and Drug Administration (FDA). While an approval decision was initially scheduled for the second quarter of 2018, that date has been pushed back by three months.
The FDA filed for a three-month extension to analyze additional information regarding the results of liver function tests. The agency now plans to make a decision by the third quarter of 2018.
The first date was decided after AbbVie’s new drug application for elagolix was granted priority review in October 2017. Priority review is given to medicines with potential to significantly improve the safety and efficacy of current treatments for serious conditions.
The regulatory boost was granted after a review of results from two Phase 3 clinical trials. In these trials, 200 mg of elagolix given twice daily for up to six months was shown to reduce the proliferation of endometrial tissue and pelvic pain. Extended treatment for up to 12 months further resulted in nearly half of the women reporting less monthly menstrual and non-menstrual pelvic pain. Data also revealed that treatment with elagolix was well-tolerated and caused no new safety concerns.
If the FDA decides to approve elagolix, it will become the first oral therapeutic strategy for endometriosis-associated pain in more than a decade.
While the FDA deliberates its decision, the endometriosis community may engage in reviewing ICER’s report, which was written in alignment with the organization’s principles and includes input from key patient and advocacy groups, clinical specialists, and manufacturers.
A draft scoping document also accepted public comments. The current draft evidence report includes some of these comments and others that were collected through community engagement.
Anyone can submit a comment to the draft evidence report and the draft voting questions until May 31 at 5 p.m. ET. All stakeholders are invited to submit formal comments by email following these guidelines.
All comments will be reviewed and incorporated, if pertinent, into the final evidence report and the revised voting questions until June 15. All comments, and ICER’s responses, will be posted publicly along with the evidence report.
In July, the ICER draft evidence report will be discussed at a public meeting of the New England Comparative Effectiveness Public Advisory Council, one of ICER’s three independent evidence-appraisal committees.
To register for the public meeting, on July 12 in Burlington, Vermont, those interested should choose whether to attend in person or follow the meeting live via webcast.
Those attending in person may also register to deliver an oral comment, which must be submitted by email by May 31 at 5 p.m. ET. Those who wish to make oral comments must register for the public meeting and send an email.