Similar to a class of compounds known as incretins (which includes glucagon-like peptide-1 (GLP-1)) Byetta is thought to exert its action by enhancing pancreatic beta-cell insulin secretion, suppression of elevated glucagon secretion, and the slowing of gastric emptying.  In all three pivotal clinical trials supporting Byetta’s original approval body weight decreased at Week 30 in the 10 mcg treatment groups.   We reviewed a 2008 Lancet article by Drucker et al involving 295 patients with type 2 diabetes which demonstrated that exenatide once weekly performed better in terms of glycemic control than exenatide twice daily over a 30 wk period with no increased risk of hypoglycemia.

Byetta, a first in class therapy,  was approved in 2005 and was originally used as an adjunctive therapy to improve glycemic control in patients with type 2 diabetes who are taking metformin, a sufonylurea, or some combination of the two and have not achieved adequate blood sugar control.  In 2009 Byetta’ s indication was expanded to include its use as a stand alone or monotherapy in addition to diet and exercise to improve blood sugar control in Type 2 diabetes.  Since the drug’s approval, safety concerns have arisen around the risk of  acute pancreatitis with complications, including death and altered kidney function associated with Byetta use. 

CDC data suggest that more than 1 000 000 Americans are diagnosed with diabetes annually and that there are in excess of 14 000 000 Americans currently afflicted with the disease. It is estimated that about 5 000 000 diabetics require daily insulin injections to control their blood sugars. Complications commonly associated with uncontrolled or poorly controlled diabetes include heart disease, stroke, kidney failure and blindness. Diabetes and its complications may account for more than $100 billion annually in healthcare costs in the United States.

At the risk of stating the obvious – we believe that if exenatide once weekly recieves FDA approval, simplification of the exenatide dosing regimen from twice daily to once weekly would be seen as very favourable by patients and physicians alike. 

Thanks for reading.

First of all, on behalf of  the entire BioHorizon staff, let me welcome you to the BioHorizon Health Technology Surveillance Update.  Long time clients  and readers will remember that Surveillance Updates last graced these pages in 2005-2006 and based on your feedback we have changed the focus of this feature to better meet your needs -  we hope you  agree!

Lets start by turning our attention to  FDA approvals of note in January and February 2010.  On January 11th, Genentech Inc.’s rheumatoid arthritis therapy, Actemra (tocilizumab),  was approved for treatment of adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes  for this disease.  Serious safety concerns associated with this interleukin-6 blocker were cited as the basis for the FDA’s requirement for a post-marketing clinical trial to evaluate long term safety as well as a Risk Evaluation and Mitigation Strategy that directs Genentech to implement a communication plan for prescribing physicians detailing the appropriate approach to obtaining informed consent and side effect monitoring.

Acorda Therapeutics’ Ampyra (dalfampridine) extended release tablets were approved on January 22nd, to improve walking in multiple sclerosis patients representing the first drug approved for this use.  The FDA cautioned that Ampyra can cause seizures when given at greater than recommended doses. 

Turning to medical devices for a moment, Thoratec Corp.’s HeartMate II Left Ventricular Assist System was approved on January 20th for severe heart failure patients who are not acceptable transplant candidates.  The HeartMate II was already approved for certain patients waiting for complex medical treatments including transplants.   The FDA directed Thoratec to conduct a post-approval study to further characterize the device’s performance.

 On January 25th,  Novo Nordisk Inc got the nod for Victoza (liraglutide (rDNA) injection) the company’s once daily GLP-1 receptor agonist which is indicated for treatment of type 2 diabetes in adults and joins Eli Lilly’s twice daily Byetta in the injectable GLP-1 agonist class.

GlaxoSmithKline’s Tykerb (lapatinib) got an expanded indication from the FDA on January 29, and can now be used in combination with the Novarits product Femara (letrozole) in the treatment of hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

And finally, on February 2nd the FDA approved Auxillium Pharmaceuticals’  injectable Dupuytren’s contracture therapy, Xiaflex (collagenase clostridium histolyticum) – this is the first FDA approved non-surgical therapy inidicated for this progressive hand disease. 

We encourage our readers to visit www.fda.gov as well a company or product specific website for more details, in subsequent weekly updates we will begin to include some discussion of interesting clinical trial results from the week that was in additon to setting the table for the next week in emerging health technology.  Thanks for reading.