BioHorizon » Elan http://www.biohorizon.com Emerging Health Technology Surveillance and Analysis Wed, 26 Oct 2011 17:27:01 +0000 en hourly 1 http://wordpress.org/?v=3.0 Elan/Biogen Idec’s Antegren (Natalizumab) for Treatment of Multiple Sclerosis http://www.biohorizon.com/2004/07/elanbiogen-idecs-antegren-natalizumab-for-treatment-of-multiple-sclerosis/ http://www.biohorizon.com/2004/07/elanbiogen-idecs-antegren-natalizumab-for-treatment-of-multiple-sclerosis/#comments Mon, 26 Jul 2004 18:33:40 +0000 admin http://www.biohorizon.com/?p=165 On July 26, 2004 Elan Corp.’s application for approval of its multiple sclerosis (MS) drug Antegren was accepted for review by the FDA. Elan has developed Antegren with U.S. partner Biogen Idec. The company has stated that this therapy represents a new approach in the treatment of MS and is expected to eventually generate annual sales of more than $1 billion. This estimate merits a 50/100 BioHorizon demand/diffusion variable score. The FDA, which granted Antegren ‘priority status’ in June 2004, will now review the New Drug Application and make its decision within 6 months as opposed to the standard 10 months. Completion of Phase III trials for the MS indication results in a BioHorizon efficacy variable score of 75/100.

Antegren is a humanized monoclonal antibody designed to inhibit the migration of immune cells into tissues where they may play a role in causing or propogating an inflammatory response. The company states that it is the first alpha-4 antagonist in the new selective adhesion molecule (SAM) inhibitor class. Approximately 2,800 patients have received natalizumab in clinical trials for both Crohn’s disease and MS; headache, fatigue, and nasopharyngitis were the most commonly reported side effects. BioHorizon has currently assigned Antegren a first in class 75/100 innovation status variable score.

Multiple sclerosis is a chronic, debilitating autoimmune disease that affects the brain and spinal cord. MS causes the body to direct antibodies and white blood cells against proteins in the myelin sheath that surrounds the nerves in the brain and spinal cord. This may cause inflammation and areas of scarring on nerves resulting in loss or decrease in function. An estimated 400,000 Americans have MS. BioHorizon utilizes an incident case number of 10, 400 new cases of MS in the U.S. per annum and assigns an 11/100 value to the burden of illness variable.

BioHorizon is currently monitoring 23 emerging technologies for the treatment of Multiple Sclerosis. Of these 23 drugs, Avonex®, Betaseron®, Rebif®, and Copaxone® are already approved for this indication while Antegren is the only Phase III technology currently in the BioHorizon database. Although currently designated as Moderate Impact technology, we feel that the high degree of innovation exhibited by this treatment and the large unmet medical need surrounding MS will result in significant technology impact. Health Services clients should commence preliminary assessment activities within the next quarter and watch for news regarding approval.

Technology Details
Target Disease / Indication: Multiple Sclerosis
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Neurology
Regulatory Status: Phase III
BioHorizon Impact Score: 53/100 – Moderate Impact

]]> http://www.biohorizon.com/2004/07/elanbiogen-idecs-antegren-natalizumab-for-treatment-of-multiple-sclerosis/feed/ 0