The drug is to inhibit the migration of immune cells into tissues where they may cause or maintain inflammation. To date, approximately 2,800 patients have received natalizumab in clinical trials, and the safety profile continues to support further development. In placebo-controlled trials so far in both Crohn’s disease and MS, the most common adverse events reported in both groups, headache, fatigue and nasopharyngitis.. 2,800 patientsEN Biologics License Application for Priority Review as a treatment for multiple sclerosisAbout ANTEGREN Natalizumab, a humanized monoclonal antibody, is the first alpha – 4 antagonist in the new selective adhesion molecule inhibitor class.
To the completion for the completion of this two-year studies. To protect the integrity of the tests, the company did not disclose the one-year data at this time.
MEDIA CONTACT:Biogen Idec Amy Brockelman Ph: 617 914 6524Elan Anita Kawatra Ph: 212 407 5755 800 252 3526INVESTOR CONTACT:Biogen Idec Elizabeth Woo Ph: 617 679 2812Elan Emer Reynolds Ph: 353 1 709 4000 800 252 3526Biogen Idec and Elan Corporation, plc today announced that the Biologics License Application for ANTEGREN reg () was) for Priority Review and Accelerated Approval by the U.S. Food and Drug Administration The next step in this process, actions by the FDA on the formal acceptance of the application, which occurs within 60 days of submission..Last Friday, DME to into the top ten invitation region bonds by the Centers for Medicare and Medicaid Services to state on whether you do a contract from bidding from the tender supply or outside of of the bidding range for a product. These DME providers which have not obtained concluded contracts for a specific Medicare item or service from the Medicare program for three years.
Not yet authorized sale in any country.
It congressionally mandated bid Programme was developed order to reduce the number of DME series suppliers and reimbursement rates for oxygen inhalation, hospital beds, wheelchairs and other kinds of home-based equipping and supply in Medicare. The reimbursement rates be already adjusted to reduce from Medicare reimbursement rates of oxygen and already been by nearly 50 % in the past 10 years. A DME industrial have long argued that this new scheme founded punishing unnecessary, high-quality providers, reducing which DME industry focus to service and harm patient access to care.