GEN Exclusives

More »

GEN News Highlights

More »
Jan 24, 2011

Switzerland and Australia Approve Novartis’ MS Drug

  • The Swiss and Australian regulatory authorities have both cleared Novartis Gilenya® (fingolimod) as first-line disease-modifying therapy for patients with relapsing-remitting multiple sclerosis (RRMS). Novartis announced the approvals just three days after EMA’s Committee for Medicinal Products for Human Use separately recommended approval of the drug within the EU. The sphingosine 1-phosphate receptor (S1PR) modulator is already approved in the U.S. and Russia.

    Gilenya’s approval in Switzerland and Australia is based on data from what Novartis claims is the largest clinical trial program conducted in MS to date. Trial data showed that treatment with Gilenya reduced relapses by 52% after a year when compared with therapy using interferon beta-1a. A two-year study also showed Gilenya led to a 54% reduction in relapse rate when compared with placebo. Patients in this trial also demonstrated a 30% lower risk of disability progression after three months, and a 37% lower risk of disability progression after six months.

    Novartis has developed Gilenya under license from Mitsubishi Tanabe Pharma.


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Companion Animal Care

Do you think Americans spend too much on companion animal care?