New formulation beta 1b Wins FDA Approval

Novartis AG won U.S. Food and Drug Administration approval to sell its Extavia multiple sclerosis treatment, its brand of Bayer AG’s Betaseron. Extavia, a form of interferon [...]

• Caroline says: The second injectable beta interferon 1b has been FDA approved. Novartis' Extavia is approved for early MS and RRMS (same as Betaseron). Novartis is looking to expand/create their MS franchise (fingolimod will be filed later this year) with Extavia.
   

• Related Links:
• http://www.bloomberg.com/apps/news?pid=20601085&sid=atoWL4lE1HUY…

• Biogen Receives FDA Fast Track Status for PEGylated Interferon Beta-1a

  July 8, 2009 Biogen Idec (NASDAQ: BIIB) today announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing [...]

  • Caroline says: I posted an article about this last week-- it's basically a new formulation of Avonex (less frequent injections) and it has been fast-tracked for FDA approval as of this morning.
     
  
  

  • Hot off the ENS Press…Rebif Autoinject Improves SC Delivery

    MILAN, Italy June 26, 2009 A new electronic, multidose, autoinjection device improves subcutaneous delivery of interferon beta (IFNB)-1a in patients with relapsing multiple sclerosis (MS), according to [...]

    • Caroline says: I've seen links to this in the last week but when I clicked on them, the link was dead...UNTIL NOW...mwah, mwah, mwah. I think it was embargoed until it was presented yesterday. Rebif is the one drug out of the CRABs (who was responsible for coming up with THAT acronym, anyway?) that I have not had the pleasure of being on. It's interferon-1a (like Avonex), only it is administered three-times weekly subcutaneously.
       
    
    

    • Teva completes enrollment in second Phase III trial

      Jun 26, 2009 (Datamonitor via COMTEX) — Teva Pharmaceutical Industries, an Israeli generic pharmaceutical company, and Active Biotech, a Swedish pharmaceutical company, have completed patient enrollment for [...]

      • Caroline says: Laquinimod is a pipeline oral MS drug. Teva and Active Biotech have completed pt enrollment for the 2nd pivotal Phase III clinical trial, Bravo, evaluating the oral once-daily immunomodulating compound, laquinimod, for the treatment of RRMS. Bravo is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod compared to placebo, and to provide risk-benefit data for laquinimod compared to a currently available injectable treatment, Avonex.
         
      
      

      • Hot off the ENS Press: Immunomodulatory Treatment Improves Cognitive Function in PWMS

        By Judith Moser, MD MILAN, Italy — June 26, 2009 — Patients with relapsing-remitting multiple sclerosis (RRMS) who receive glatiramer acetate (GA) or interferon (IFN) beta show [...]

        • Caroline says: 752 pts with RRMS were enrolled in 79 Italian centers and treated with either glatiramer acetate or interferon beta. After 2 years, a significant reduction in cognitive impairment was observed. At baseline, 40% of all patients showed mild cognitive impairment, and 16% showed severe cognitive impairment, which the researchers said was reduced to 30% and 11%, respectively, at 2 years.
           
        
        

        • Hot off the ENS Press: Cladribine Is Safe Overall in Patients With Multiple Sclerosis

          MILAN, Italy — June 24, 2009 — According to a safety analysis of a study presented here at the 19th Meeting of the European Neurological Society (ENS), [...]

          • Caroline says: This is good news for people who are excited about orals. Cladribine seems to be the safer option out of the ones that are coming out soon. Incidence of treatment-emergent AE's in the trial of 1326 RRMS patients were comparable between 2 doses of cladribine and placebo. As expected based on the MOA of cladribine, lymphopenia (low white blood cells) occurred with the highest incidence in patients receiving the higher dose of the drug.
             
          
          

          • Hot off the AAN Press: Laquinimod, New Data, Novel MOA

            New Data Illustrate Novel Mechanism OF Action of Laquinimod, an Oral Compound for the Treatment of Multiple Sclerosis -Researchers Demonstrate Immunomodulatory Effects of Laquinimod on Disease Activity [...]

            • Caroline says: Teva/Active Biotech presented data on their oral RRMS drug laquinimod-- and it's novel MOA, which modulates the immune system, suggesting immunomodulating effects within the CNS. A Phase IIb study in 306 patients found that an oral 0.6 mg dose of laquinimod QD significantly reduced MRI disease activity by a median of 60%. So far this is the only oral in the pipeline that I can see with no significant side effects. Good news.
               
            
            

            • Hot off the AAN Press: Study Suggests Copaxone has Protective Effects

              Long-Term Study with COPAXONE® Indicated Protective Effect on Brain Tissue in Multiple Sclerosis Patients – New Data Presented at 61st Annual Meeting of the American Academy of [...]

              • Caroline says: Data from a 6-year study suggests that Copaxone may have neuroprotective effect in RRMS. It was the largest and longest study of its kind to date.