Date: December 20, 2014
First, to learn how to say these pharma names of these emerging therapies
Daclizumab (Dac-li-zu-mab) (trade name Zenapax)
is a therapeutic humanized monoclonal antibody. It is used to prevent rejection in organ transplantation, especially in kidney transplants. The drug is also under investigation for the treatment of multiple sclerosis.
BIOGEN IDEC AND ABBVIE ANNOUNCE POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY INVESTIGATING DACLIZUMAB HIGH-YIELD PROCESS IN MULTIPLE SCLEROSIS
− DAC HYP Demonstrated Superiority Over Interferon Beta-1a in Annualized Relapse Rate –
− Positive Results Set Stage for Regulatory Filings –
CAMBRIDGE, Mass. & NORTH CHICAGO, Ill. –
Biogen Idec and
AbbVie announced positive top-line results from the Phase 3 DECIDE clinical trial, designed to evaluate the superiority of once-monthly, subcutaneous daclizumab high-yield process (DAC HYP) when compared to intramuscular interferon beta-1a (IFN β-1a), as a potential treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). Results showed that DAC HYP was superior on the study’s primary endpoint, demonstrating a statistically significant 45 percent reduction in annualized relapse rate (ARR) compared to IFN β-1a (p<0.0001).
“The results of the DECIDE study are compelling, with DAC HYP demonstrating robust efficacy compared to a current standard of MS care,” said Gilmore O’Neill, vice president, Global Neurology Clinical Development, Biogen Idec. “As a potential once-monthly therapy with a novel mechanism of action, we believe that, if approved, DAC HYP will be an important treatment option for people living with MS.”
Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T cells. The drug is marketed in the US, but not in Europe
Read more here
Ocrelizumab (Ocre-li-zu-mab)
is a humanized anti-CD20 monoclonal antibody. It targets mature B lymphocytes and hence is an immunosuppressive drug candidate. It is under development by Hoffmann–La Roche’s subsidiary Genentech, and Biogen Idec.
Ocrelizumab in MS: Encouraging Long-term Data
Long-term follow-up of patients with multiple sclerosis (MS) in the phase 2 trial of ocrelizumab suggest that the drug continues to be effective for up to 18 months after the last dose, with no new safety concerns identified.
The latest data from the phase 2 study with the drug, a humanized monoclonal antibody targeted against CD20-expressing B cells, were presented by lead investigator Stephen Hauser, MD, here at the American Academy of Neurology (AAN) 65th Annual Meeting last week.
Results showed that patients having up to 4 treatment cycles of ocrelizumab and followed for as long as 18 months after the last dose had minimal new MRI activity and a low level of clinical disease activity. In addition, there were no new safety concerns and no reports of opportunistic infections.
“Major Blockbuster”?
READ MORE HERE
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