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.

Enbrel is a protein that is thought to exert its action through the binding and subsequent inactivation of a naturally produced cytokine known as Tumor Necrosis Factor (TNF). TNF is produced by the body’s immune system. In patients with psoriasis and other autoimmune diseases, certain immune cells increase production of TNF. This increased TNF activity is thought to be critical in mediating the overactive immune response that causes the tissue damage that is a hallmark of psoriasis and rheumatoid arthritis. Amgen has indicated that approximately 234,000 patients have already been treated with Enbrel worldwide. Amgen reports total sales of Enbrel for 2003 in the 1.3 billion dollar range.

The true incidence of psoriasis in the United States is difficult to determine. Estimates of prevalence suggest that approximately 4.5 million people are affected by psoriasis with approximately one third of these suffering from the ‘plaque’ type of the disease. Psoriasis is characterized by the development of red, itchy skin plaques that are often painful and disfiguring.

Enbrel satisfies all BioHorizon criteria for High Impact Technologies: it is an innovative therapy, it has diffused rapidly, it has demonstrated efficacy in clinical trials, and with this most recent approval, it is indicated for more prevalent conditions. In light of the psoriasis indication, clients should begin or revisit assessment activities at this time.

Technology Details
Target Disease / Indication: Psoriasis
Technology Classification: Drug
Body System: Dermatologic
Program Area: Medicine/Infectious Disease
Regulatory Status: Phase III
BioHorizon Impact Score: 63/100-Moderate/High Impact

Enbrel is a protein that is thought to exert its action through the binding and subsequent inactivation of a naturally produced cytokine known as Tumor necrosis factor (TNF). TNF is produced by the body’s immune system, and in patients with psoriasis and other autoimmune diseases, certain immune cells increase production of TNF. This increased TNF activity is thought to be critical in mediating the overactive immune response that causes the tissue damage that is a hallmark of psoriasis and rheumatoid arthritis. Amgen has indicated that approximately 234,000 patients have already been treated with Enbrel worldwide. Amgen reports total sales of Enbrel for 2003 in the 1.3 billion dollar range

The true incidence of psoriasis in the United States is difficult to determine. Estimates of prevalence suggest that approximately 4.5 million people are affected by psoriasis with approximately one third of these suffering from the ‘plaque’ type of the disease. Psoriasis is characterized by the development of red, itchy skin plaques that are often painful and disfiguring.

Enbrel satisfies all Biohorizon criteria for High Impact Technologies: it is an innovative therapy, it has diffused rapidly, it has demonstrated efficacy in clinical trials, and with this most recent approval, it is indicated for more prevalent conditions. In light of the psoriasis indication, clients should begin or revisit assessment activities at this time.

Technology Details
Target Disease / Indication: Psoriasis
Technology Classification: Drug
Body System: Integumentary System
Program Area: Medicine/Dermatology
Regulatory Status: Approved
BioHorizon Impact Score: 76/100 – High

Humira is a human monoclonal antibody that is thought to exert its effect by interfering with the function of an inflammatory cytokine known as tumor necrosis factor alpha (TNF-a). TNF-a is thought to play a critical role in mediating the immune response that causes the signs and symptoms of rheumatoid arthritis and other autoimmune diseases. Humira is given subcutaneously by injection every two weeks. Other currently existing treatments for rheumatoird arthritis include Enbrel®, and Remicade® (both TNF-a biological response modifiers) and Amgen’s Kineret® (an Interleukin-1 inhibitor), all of which are relatively new.

Rheumatoid arthritis is a chronic autoimmune disease that causes pain and swelling of the joints and may progress to the point of joint destruction. It has been estimated that the incidence of rheumatoid arthritis in the United States is 70/100, 000 per year, with 1 to 2 % of the population ultimately affected.

Biohorizon has currently assigned Humira to the High Impact Technology category. At approximately $1200 per patient per month, it produces a significant cost increase when compared to the traditional disease modifying anti-rheumatic drugs such as methotrexate. Based on Abbott’s own reported and predicted sales numbers, diffusion seems to be occurring at an impressive rate. Biohorizon reiterates the need for health services organizations to plan for the continued and increased presence of Humira in rheumatoid arthritis treatment regimens.

Technology Details
Target Disease / Indication
Rheumatoid Arthritis

Technology Classification
Drug

Body System
Musculoskeletal System

Program Area
Medicine/Rheumatology

Regulatory Status
Approved

BioHorizon Impact Score
67/100 – High