#CMSC17 – Celgene’s Investigational Therapy Ozanimod Safe, Effective in Treating Relapsing MS, Clinical Trial Finds

Long-term treatment for up to 12o weeks, with the investigational drug Ozanimod (RPC-1063), found to be effective and safe in patients with relapsing multiple sclerosis (MS) who participated in the RADIANCE clinical trial. Celgene, Ozanimod’s developer, presented the study, “Efficacy and Safety of Ozanimod in the Blinded Extension (120…

Results of Phase 3 Trial for Celgene’s Ozanimod Suggest Therapeutic Benefit in RMS Patients

Relapsing multiple sclerosis (RMS) patients taking the investigational drug ozanimod, also known as RPC-1063, had lower relapse rate than those on weekly Avonex (interferon β-1a) therapy, according to Celgene in an announcement updating results of its Phase 3 RADIANCE trial. Ozanimod is a new orally administrated drug that selectively inhibits the…

Diplomat Pharmacy Chosen to Dispense Ocrevus to MS Patients Across US

Diplomat Pharmacy, the largest independent specialty pharmacy in the U.S., has been selected to dispense Ocrevus (ocrelizumab), a limited-distribution drug, to people with relapsing  and primary progressive multiple sclerosis. Ocrevus was approved by the U.S. Food and Drug Administration on March 28, becoming the first therapy approved for both RMS and…

Ocrevus’ Journey from Defiant Idea to Game-Changing Treatment

Twenty years ago, the idea that B-cell depletion could treat multiple sclerosis would have been greeted with a hearty laugh by any well-respected neurologist or MS researcher — or perhaps a scoff. But times change and research advances. Today, a medicine that gets rid of certain B-cells may be the most powerful drug yet developed against…

Copaxone Use During Pregnancy by RMS Patients Now Possible in EU

European users of Copaxone (glatiramer acetate injection, Teva Pharmaceutical) to treat relapsing forms of multiple sclerosis (RMS) will no longer see a warning that the drug should not be used during pregnancy. A report assessing this change in the drug’s marketing authorization within the European Union — a process known as…

NICE Planning to Reject MS Treatment, Zinbryta, in England and Wales

The National Institute for Health and Care Excellence (NICE), the health authority for England and Wales, has decided not to recommend Zinbryta (daclizumab) be made available to multiple sclerosis (MS) patients through the country’s health service. The decision came in a first stage of the drug’s review process, and NICE is welcoming…

Phase 3 Study to Test Oral Combination, Tecfidera and Ponesimod, to Treat Relapsing MS

Actelion announced that it will investigate the therapeutic potential of a new, oral combination therapy with ponesimod and Tecfidera (dimethyl fumarate) as a treatment for relapsing multiple sclerosis (RMS). The Phase 3 clinical study, being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), aims to find…

Genentech Enrolling Relapsing MS Patients in Study of Mechanism of Action for Ocrevus

In addition to a new study sponsored by Genentech to test the experimental MS therapy Ocrevus (ocrelizumab) in RMS patients who have had a sub-optimal response to previous disease modifying therapies, the company is also currently recruiting patients with relapsing multiple sclerosis to understand the therapy’s mechanism of action and B-cell biology…

1st Potential Therapy for Primary Progressive MS, Ocrelizumab, Under Priority Review by FDA

The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If the company’s Biologics License Application (BLA) is approved, Ocrevus will become the first drug able to treat patients with either relapsing or…

Roche to Pursue MS Ocrelizumab Drug Market Authorization

Roche recently provided an update on their late-stage pipeline products across several therapeutic areas, including ocrelizumab for the treatment of multiple sclerosis. The data was disclosed on Nov. 5 at the Roche Pharma Day 2015 event in London, U.K. Ocrelizumab was previously revealed to be the first investigational medicine…