Trends-in-Medicine| Publisher: | Stephen Snyder |
| Writers: | Lynne Peterson |
| Marta Weber | |
| Diana Woods | |
| Editors: | Kathleen Snyder |
| Betty Teel | |
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2011
No articles may be reproduced without written permission of the publisher.
Return Home
July 2011 Issues
FDA Advisory Committee Rejects Bristol-Myers Squibb and Astrazeneca’s Diabetes Drug, Dapagliflozin -- Quick Pulse
Summary: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted against approval of Bristol-Myers Squibb (BMS) and AstraZeneca’s dapagliflozin, a first-in-class sodium glucose cotransporter-2 (SGLT-2) inhibitor “as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes when used as either monotherapy or an add-on to other oral antidiabetic agents or added to insulin.” The panel rejected dapagliflozin by a vote of 9 to 6, citing concerns about data, long-term effects of the drug, efficacy (particularly in renally impaired patients), and safety, especially breast and bladder cancer and hepatic toxicity.
2731 N.E. Pinecrest Lakes Boulevard, Jensen Beach, FL, 34957, 772-334-7409, Fax 772-334-0856
Email webmaster about site: mike@bookcase.com
