Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

UsernamePublicRestriction
UsernamePublicRestriction

Panel Continues To Push For Obesity CV Guidance As It Backs Contrave Approval

Executive Summary

FDA signaled during an advisory committee on Orexigen's weight-loss drug Contrave that it could be ready to revise its obesity drug draft guidance, particularly with regard to cardiovascular goals, but stressed that for now, the drugs under review are to be judged by standards articulated in the draft document.

You may also be interested in...



New Paradigm Would Open More Avenues To Obesity Drug Approval

Assessments of obesity drugs should look at their effects in patients grouped by health status and FDA should expand the universe of secondary endpoints available to assess benefits, a group of stakeholders says.

Obesity Drug Approval Needs A New Paradigm, Stakeholder Group Says

Group convened by George Washington University School of Public Health and Health Services recommends a “patient-centered” approach to reviewing obesity drugs that includes assessing the therapies for their risks and benefits for obese individuals who are healthy, have risk factors for co-morbidities or impairments to daily feeling or functioning, or are already sick.

Belviq Gains FDA Approval For Weight Loss, But DEA Review Will Delay Launch

With a July 17 user fee date, Vivus’ obesity drug Qnexa could beat Arena Pharmaceuticals’ Belviq to the marketplace as lorcaserin awaits controlled substance scheduling by the Drug Enforcement Agency.

Related Content

Topics

UsernamePublicRestriction

Register

RS150923

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

Cancel