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

Dapagliflozin’s CV Profile Shines, But FDA Panel Review Falls On Cancer Concerns

Executive Summary

The July 19 FDA advisory committee meeting on Bristol-Myers Squibb Co./AstraZeneca PLC's dapagliflozin reflects the hurdles facing type 2 diabetes drug sponsors even when cardiovascular safety concerns are taken out of the picture.

You may also be interested in...



AstraZeneca’s Farxiga Label Includes, But Downplays, Bladder Cancer Risk

AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin) finally clears FDA, and without a black box warning on bladder cancer risk – allowing the drug to compete with J&J’s first-to-market Invokana.

FDA Panel Questions Role Of CV Safety Meta-Analyses At Dapagliflozin Review

Agency’s 2008 guidance allows diabetes drug sponsors to exclude a threshold level of increased cardiovascular risk pre-approval through a meta-analysis of clinical trials; however, panelists reviewing Bristol/AstraZeneca’s SGLT-2 inhibitor questioned the usefulness of meta-analyses when they are based primarily upon short-term studies in patients unlikely to have events.

Dapagliflozin Passes CV Safety Test For Now; FDA Panel Eyes Outcomes Study

Members of the Endocrinologic and Metabolic Drugs Advisory Committee endorse approval of Bristol/AstraZeneca’s SGLT-2 inhibitor, believing that the ongoing 17,000-patient DECLARE trial will supply needed answers around cardiovascular and bladder cancer concerns.

Related Content

Topics

UsernamePublicRestriction

Register

ID1132046

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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