Biogen & Alkermes announce that the U.S. FDA has accepted for review the New Drug Application (NDA) for diroximel fumarate in multiple sclerosis (MS). The drug, diroximel fumarate, is a novel oral fumarate in development for the treatment of relapsing forms of MS. The approval has a target action date in the fourth quarter of
Novartis is seeking approval from EU and US for use of experimental multiple sclerosis therapy, siponimod, to treat secondary progressive forms of MS. Secondary progressive multiple sclerosis (SPMS) is where the disease causes continuous worsening of neurological function over time, independent of relapses. Most people with relapsing remitting forms of MS will eventually go on
Gilenya, which the FDA first approved in adults back in 2010, has had its approval expanded to treat relapsing multiple sclerosis (MS) in children and adolescents over the age of 10 years. This is the first FDA approval of a drug to treat MS in paediatric patients. “For the first time, we have an FDA-approved
Merck’s Mavenclad is being backed by NICE as an option for treating highly active multiple sclerosis in adults on the NHS. In a Final Appraisal Determination, the cost watchdog is recommending routine funding for the drug if the patient has rapidly evolving severe relapsing-remitting multiple sclerosis, that is, at least two relapses in the previous
Biogen and AbbVie have announced that the European Commission has given marketing authorisation for Zinbryta, to be used as treatment of adult patients with relapsing forms of multiple sclerosis. “With the approval of Zinbryta in the European Union, we are providing a much needed treatment option for people living with MS,” added Michael Severino, M.D.,
Roche and AstraZeneca have received US FDA breakthrough therapy designations for treatments in multiple sclerosis (MS) and bladder cancer, respectively. Roche’s Ocrevus (ocrelizumab) has become the first investigational medicine to receive the designation for MS. Specifically, the drug treats primary progressive multiple sclerosis (PPMS), a debilitating form of the disease characterised by steadily worsening symptoms
A few days after confirming that a patient died 24 hours after beginning treatment with Gilenya, Novartis today announced positive data from an additional major late-stage study of their multiple sclerosis drug. Results from the 1,083-patient Phase III 2309 trial revealed that sufferers with relapsing-remitting multiple sclerosis (MS) treated with Gilenya (fingolimod) had a 48%
