Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA Goes To Committee With Uncertainty About Metreleptin Efficacy For Partial Lipodystrophy

This article was originally published in The Pink Sheet Daily

Executive Summary

The Dec. 11 Endocrinologic and Metabolic Drugs Advisory Committee also will consider whether a proposed Risk Evaluation and Mitigation Strategy would address the possible risk for lymphoma and immunogenicity with Bristol-Myers Squibb/AstraZeneca’s drug.

You may also be interested in...

FDA Approvals, In Brief

Agency clears Amylin’s metreleptin, expands the use of Vertex’s Kalydeco and approves a novel formulation of indomethacin from Iroko, and Pfizer’s Prevnar 13 moves closer to getting a CDC recommendation to match its FDA approval for use in older adults.

Metreleptin Needs Tighter Partial Lipodystrophy Indication, Panel Says

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of the Bristol/AstraZeneca drug to treat generalized lipodystrophy but rejected the proposed partial lipodystrophy indication as too broad.

FDA Panel Accepts Metreleptin For Generalized Lipodystrophy, No Further Criteria Needed

Members of the Endocrinologic and Metabolic Drugs Advisory Committee say there is no data to support limiting Bristol-Myers Squibb/AstraZeneca’s drug to a subpopulation.

Related Content

Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts