BioHorizon Health Technology Surveillance Update: February 8, 2010
February 8, 2010 by tim · Leave a Comment
The BioHorizon Health Technology Surveillance Update gives readers a concise, high level overview of the most important emerging health technology developments on a ongoing basis including key FDA approvals, substantive clinical trial results and upcoming events of importance.
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.