Long-awaited approval of the multiple sclerosis drug Ocrevus (ocrelizumab) has been delayed by the U.S. Food and Drug Administration. What had been publicized widely as a late December 2016 FDA approval hearing has now been pushed to late March 2017. The drug’s manufacturer, Genentech, issued a very…
Drug approval
The U.S. Food and Drug Administration recently extended until the end of March its review of the Biologics License Application (BLA) for Ocrevus (ocrelizumab). The application was submitted by Roche, requesting FDA approval for Ocrevus as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) and — for a first…
Health Canada has approved Zinbryta (daclizumab) as a treatment for adults with active relapsing-remitting multiple sclerosis (RRMS), Biogen and AbbVie announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies. “ZINBRYTA™ is the first once-monthly, self-administered treatment…
Neurologists in the U.S. expect — or, at least, highly anticipate — that Ocrevus (ocrelizumab), being developed by Roche as a treatment for both relapsing and progressive multiple sclerosis (MS), will be approved by year’s end, and a sizable number plan on quickly prescribing it, according to a recent update by Spherix…
Health Canada has approved Teva Canada Innovation‘s three-time weekly 40 mg/mL injection of Copaxone (glatiramer acetate) that allows less frequent dosing for patients with relapsing-remitting multiple sclerosis (RRMS). The approval was grounded primarily on data resulting from the Phase 3 Glatiramer Acetate Low-Frequency Administration (GALA) study, the largest Copaxone clinical…
Merck KGaA, Darmstadt, Germany recently announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the company’s investigational product Cladribine Tablets as a therapy for relapsing multiple sclerosis (RMS) in Europe. Cladribine is a synthetic antineoplastic agent able to suppress the immune system, causing relatively few…
We wait in anticipation for multiple sclerosis (MS) drugs to clear Phase 3 clinical trials and get to the Food and Drug Administration (FDA) for approval, but I honesty knew little of the process that takes place before the large-scale testing of drugs in Phase 3. I was selected to…
Biogen and AbbVie announced that the drug Zinbryta (daclizumab) has received marketing authorization by the European Commission, and is an approved treatment across most of Europe for adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a self-administered, once monthly subcutaneous injection. “Clinical data showed Zinbryta significantly reduced relapses, 24-week…
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…
Biogen, announced that TYSABRI, a drug developed to treat people with multiple sclerosis (MS) has received a positive opinion from the European Medicine Agency (EMA) recommending its approval to be used in people with elapsing-remitting multiple sclerosis (RRMS).
Zinbryta (daclizumab) was approved May 27 for the treatment of adults with relapsing multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) cleared Biogen’s new long-acting injection as a patient self-administered monthly therapy. The director of Neurology Products at the U.S. FDA’s Center for Drug Evaluation…
The Russian Ministry of Health recently granted Marketing Authorization (ЛП-003567) to R-Pharm JSC for the development of “Glatirat” (Glatiramer acetate), a drug intended for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome. According to a press release, the registration of “Glatirat” was based…
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently recommended marketing authorization to Zinbryta (daclizumab) for the treatment of patients with relapsing multiple sclerosis (RMS). Zinbryta (daclizumab HYP) is a humanized monoclonal antibody that is injected every four weeks, and being developed by…
MediciNova, Inc., announced that MN-166 (ibudilast) has been approved for “fast track” development by the U.S. Food and Drug Administration (FDA) as a potential treatment for progressive multiple sclerosis (MS). Progressive MS includes both the primary progressive (PPMS) and secondary progressive (SPMS) forms of the disease. MediciNova’s MN-166 was licensed from Kyorin Pharmaceuticals for its potential…
Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment for primary progressive multiple sclerosis (PPMS), Breakthrough Therapy Designation based on positive Phase 3 clinical trial results showing that ocrelizumab significantly reduced disability progression and other disease activity markers compared to placebo. The FDA designation is…
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…
Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day, recently announced the approval of a Marketing Authorization license (MA) by the Russian Ministry of Health for three-times-per-week COPAXONE®(glatiramer acetate injection) 40 mg/mL, a new dose of COPAXONE®,…
Osmotica Pharmaceutical Corp. recently announced that the FDA accepted its New Drug Application (NDA) for OntinuaTM ER.
Teva Pharmaceutical Industries Ltd., a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions, recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the once per day 20 mg injection of COPAXONE® as prophylaxis for relapses in multiple sclerosis (MS). Glatiramer acetate, the active…
Bayer HealthCare is pleased to announce the US Food and Drug Administration (FDA) has granted the approval of BETACONNECT, a first-of-its-kind electronic autoinjector indicated as a treatment for relapsing-remitting multiple sclerosis (RRMS). For now, the drug delivery device is only compatible with BETASERON® (interferon beta-1b), and will soon be available come early 2016. While…
Merck recently reported its intention to file for European registration of its product candidate for relapsing multiple sclerosis – Cladribine, a synthetic anti-cancer agent able to suppress the immune system. Cladribine causes relatively few side effects and results in very little non-target cell loss. Merck’s decision follows new findings and further characterization of…
Relapsing remitting multiple sclerosis (RRMS) treatment Plegridy (peg interferon beta-1a) by Biogen Idec, has just received Welsh NHS approval, which should make it available to patients by late October 2015. The decision follows NHS Scotland’s approval earlier this year, however, the biweekly interferon beta shot has yet to be made available in England’s NICE…
Genzyme Canada has announced that Health Canada has approved its 14 mg dose of AUBAGIO as an expedited exception benefit product through the federal health regulator’s Non-Insured Health Benefits (NIHB) Program for eligible First Nations people and Inuit as a first-line oral tablet therapy for relapsing remitting multiple sclerosis (RRMS).
The U.S. Food and Drug Administration (FDA) has announced it will consider marketing approval of ZINBRYTA (daclizumab high-yield process), a potential treatment for relapsing forms of multiple sclerosis (MS). Biogen and AbbVie, who are jointly developing the therapy, have filed a Biologics License Application…
Bayer HealthCare recently announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a supplemental Biologics License Application (sBLA) for BETACONNECT for the treatment of relapsing-remitting multiple sclerosis (MS). BETACONNECT is a new drug delivery option for patients under Bayer’s BETASERON® (interferon beta-1b) therapy. MS is a…
The U.S. Food and Drug Administration (FDA) has announced the approval of the first generic version of Copaxone (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (MS). The administration has granted Sandoz marketing authorization for glatiramer acetate in 20 mg/1 ml…
The Scottish Medicines Consortium has just approved Biogen Idec’s Plegridy (peg interferon beta-1a) for the treatment of relapsing multiple sclerosis (MS) in patients between 18 to 65 years old, making the Consortium the first United Kingdom-based regulatory body to endorse the disease-modifying drug on the…
Takeda Pharmaceutical Company Limited (Takeda) announced late last month its New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the multiple sclerosis relapse prevention drug glatiramer acetate (active ingredient) — which is sold in some markets under the trade name Copaxone. Developed by Israel’s Teva Pharmaceutical Industries…
Ipsen Biopharmaceuticals, Inc announced that the United States Food and Drug Administration (FDA) has agreed to review the supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) to treat upper limb spasticity, a condition that affects many people in the United States, including multiple sclerosis (MS)…
Cambridge, Massachusetts based Genzyme announced Friday that the U.S. Food and Drug Administration (FDA) has approved the company’s new drug Lemtrada (alemtuzumab) for treatment of people with relapsing forms of multiple sclerosis, which includes people who experience periodic MS attacks, such as those who have relapsing-remitting MS or secondary-progressive…