Claim: Biogen multiple sclerosis drug Tecfidera wins European approval.
Verdict: SUPPORTS

Retrieved passages:
title: Dimethyl fumarate
text: for MS, and in 2010 the Danish company Forward Pharma acquired Aditech's patents. Meanwhile, Biogen continued developing its oral formulation of DMF from Fumapharm under the code name BG-12; it was approved, under the trade name Tecfidera, for the treatment of adults with relapsing forms of MS in March 2013. Biogen priced the drug at $54,000 per year in the US. It was approved in Europe in 2014. In the UK NICE issued a guidance recommending the drug as cost-effective, but only if person does not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis and only if Biogen

title: Management of multiple sclerosis
text: that inhibits the synthesis of pyrimidine and disrupts the interaction of T cells with antigen presenting cell. Fingolimod and teriflunomide are taken through a daily single dose. In 2013 one further oral drug, dimethyl fumarate -or BG12- (which is an improved version of fumaric acid, an already existing drug), was approved by the FDA. Dimethyl fumarate is taken twice daily. Another oral drug, cladribine, was approved in Russia and Australia in 2010. Its application was rejected by the FDA and EMEA in 2011 due to safety concerns in spite of the promising efficacy of the drug. This led the pharmaceutical

title: Cladribine
text: announced it would again seek regulatory approval with data from the completed clinical trials in hand, and in 2016 the EMA accepted its application for review. On June 22, 2017, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the treatment of relapsing forms of multiple sclerosis. Finally, after all these problems it was approved in Europe on August 2017 for highly active RRMS. Cladribine is an effective treatment for relapsing remitting MS, with a reduction in the annual rate of relapses of 54.5%. These effects may

title: Multiple sclerosis drug pipeline
text: list has been recently joined by cladribine, but only in Europe by now. It is approved for highly active relapsing multiple sclerosis. It has been approved in August 2017, as explained in a press release of its manufacturer (Merk). It has been approved for Europe with the name Mavenclad and is under review by FDA There are few reports comparing these treatments in front of each other. Restricting the research only to relapses, it seems that alemtuzumab is the most cost effective. Due to the aggressiveness of some medications they are classified into first and second lines. First line includes

title: Multiple sclerosis research
text: will be. It is the last stage of drug development and is followed by a submission to the appropriate regulatory agencies (e.g., European Medicines Agency (EMEA) for the European Union, the Food and Drug Administration (FDA) for the United States, Therapeutic Goods Administration (TGA) for Australia, etc.) to obtain approval for marketing. Treatment in MS phase III studies is usually 2 years per patient. Currently there are several ongoing phase III trials, and there are also some drugs that are waiting for approval after finishing theirs. For example, Cladribine (under development by Merck Serono; anticipated brand name: "Movectro") is a

title: Nivolumab
text: its subsidiary Genentech) with atezolizumab, GlaxoSmithKline in collaboration with the Maryland biotech company Amplimmune; and Teva in collaboration with the Israeli biotech company CureTech competing. Ono received approval from Japanese regulatory authorities to use nivolumab to treat unresectable melanoma in July 2014, which was the first regulatory approval of a PD-1 inhibitor anywhere in the world. Merck received its first FDA approval for its PD-1 inhibitor, pembrolizumab (Keytruda), in September 2014. Nivolumab received FDA approval for the treatment of melanoma in December 2014. In April 2015, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended

title: Tafamidis
text: submitting an application for marketing approval in Europe in early 2010. FoldRx was acquired by Pfizer later that year. During its development tafamidis was called Fx-1006A, FX1006A, PF-06291826, and PF-6291826. Tafamidis was approved by the European Medicines Agency in November 2011 to delay peripheral nerve impairment in adults with transthyretin-related hereditary amyloidosis. The FDA rejected the application for marketing approval in the US in 2012 on the basis that the clinical trial did not show efficacy based on a functional endpoint, and the FDA requested further clinical trials. The drug was approved in Japan in 2013; regulators there made the

title: Rasagiline
text: share the costs and obtained the joint right to market the drug in Europe. In 2003 Teva partnered with Eisai, giving Eisai the right to jointly market the drug for Parkinson's in the US, and to co-develop and co-market the drug for Alzheimers and other neurological diseases. It was approved by the European Medicines Agency for Parkinson's in 2005 and in the US in 2006. Rasagiline was tested for efficacy in people with multiple system atrophy in a large randomized, placebo-controlled, double-blind disease-modification trial; the drug failed. Teva conducted clinical trials attempting to prove that rasagiline did not just treat

title: Laquinimod
text: reduce relapses in MS among patients beyond a placebo. However, the final results of above-mentioned phase III trial proved oral laquinimod administered once daily slowed the progression of disability and reduced the rate of relapse in patients with relapsing–remitting multiple sclerosis. On May 7, 2013 laquinimod was approved by the Russian Ministry of Health (the FDA analog) as a treatment for relapsing-remitting multiple sclerosis (RRMS) under the brand name Nerventra. Laquinimod Laquinimod is an experimental immunomodulator developed by Active Biotech and Teva. It is being investigated as an oral treatment for multiple sclerosis (MS). Laquinimod is the successor of Active

title: Multiple sclerosis drug pipeline
text: active principles approved which are: Two interferons (interferon beta-1a and interferon beta-1b), glatiramer acetate, mitoxantrone, fingolimod, teriflunomide, dimethyl fumarate and finally three monoclonal antibodies (natalizumab, alemtuzumab and since May 2016 daclizumab) Summarizing in a table which combinations have been tried: Personalized treatment or theranostics in MS is an active field or research. Currently is trying to predict the response to the different known medications. Beta-interferons are contraindicated in cases of anti-AQP4 or anti-MOG seropositivity. Interferon injections can induce neutralising antibodies against them, turning the medication ineffective. IFN-β 1b is more immunogenic than IFN-β 1a, and the subcutaneous administration has a

title: Natalizumab
text: in people with multiple sclerosis, as well as increasing rates of remission and preventing relapse in Multiple Sclerosis. Natalizumab was approved in 2004 by the U.S. Food and Drug Administration (FDA). It was subsequently withdrawn from the market by its manufacturer after it was linked with three cases of the rare neurological condition progressive multifocal leukoencephalopathy (PML) when administered in combination with interferon beta-1a, another immunosuppressive drug often used in the treatment of multiple sclerosis. After a review of safety information and no further deaths, the drug was returned to the US market in 2006 under a special prescription program.

title: Natalizumab
text: monotherapy because the initial cases of PML, and later the fatalities, were said by the manufacturers to be linked to the use of previous medicines by the patients. Biogen Idec announced the initiation of the first clinical trial of natalizumab as a potential cancer treatment as of September 5, 2008. Natalizumab is FDA-approved for the treatment of multiple sclerosis; in the US it is also used for Crohn's disease. Natalizumab offers a limited improvement in efficacy compared to other treatments for MS, but due to the lack of information about long-term use, as well as potentially fatal adverse events, reservations

title: Daclizumab
text: Daclizumab Daclizumab (trade name Zinbryta, by Biogen) is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T-cells. In March 2018, it was voluntarily withdrawn from the market by Biogen and Abbvie after reports of encephalitis in Europe. Daclizumab was used to treat adults with relapsing forms of multiple sclerosis. It is administered subcutaneously. In clinical trials it showed 45% decrease in annualized relapse rate, a 41% reduction in the proportion of patients who relapsed,

title: Cancer vaccine
text: of a phase III clinical trial. The approval is for a subset of kidney cancer patients who are at intermediate risk for disease recurrence. It awaits approval in the US and EU. but will need a new trial for FDA approval. Interim results from a phase III trial of talimogene laherparepvec in melanoma showed a significant tumour response compared to administration of GM-CSF alone. Oncophage was approved in Russia in 2008 for kidney cancer. It is marketed by Antigenics Inc. Sipuleucel-T, Provenge, was approved by the FDA in April 2010 for metastatic hormone-refractory prostate cancer. It is marketed by Dendreon

title: Multiple sclerosis research
text: use in multiple sclerosis patients., but in 2011 the company decided to stop selling the tablets in Russia and Australia though it was already approved in this countries. Nevertheless, it seems that approval process continued in Europe and the EMEA has accepted a review process The following drugs, at least, are also in phase III (for a complete list see Multiple sclerosis drug pipeline): Relapsing-Onset variants (RO), even when they turn into progressive, have proved easier to treat than Progressive-Onset variants. Though difficult to treat, Secondary progressive and Progressive-Relapsing are easier to treat than PPMS. Only Mitoxantrone has been approved

title: Management of multiple sclerosis
text: the myelin sheath of nerves with which it competes for presentation to T cells . It is injected subcutaneously on a daily basis. Mitoxantrone is an immunosuppressant also used in cancer chemotherapy which was approved for MS in the year 2000; whereas natalizumab is a monoclonal antibody that was initially approved in 2004. Both are given by intravenous infusion at monthly intervals in the case of natalizumab and every three months in the case of mitoxantrone. In 2010 fingolimod, a sphingosine-1-phosphate receptor modulator, became the first oral drug approved by the FDA, being followed in 2012 by teriflunomide, a drug

title: Talimogene laherparepvec
text: brand OncoVEX. Development was continued by Amgen, which acquired BioVex in 2011. BioVex was founded in 2000, based on research by Robert Coffin at University College London, and moved its headquarters to Woburn, Massachusetts in 2005, leaving about half its employees in the UK. The phase II clinical trial in melanoma was published in 2009 and the phase III trial was published in 2013. T-vec was approved by the U.S. Food and Drug Administration to treat melanoma in October 2015. It was the first approval of an oncolytic virus in the West. It was provisionally approved by the European Medicines

title: Belimumab
text: of TACI by APRIL and BLyS. It failed a phase II trial for multiple sclerosis. Blisibimod, an inhibitor of both soluble and membrane bound BAFF, has demonstrated similar reductions of B cells in clinical trials and is being investigated in a phase 2 clinical study for patients with lupus erythematosus. BR3-Fc is a recombinant fusion protein built with the extracellular ligand-binding portion of BAFF-R. It blocks activation of this receptor by BLyS, and is in early stage pharmaceutical development. Of anti-CD20 monoclonal antibodies, rituximab has been approved for some indications. Ocrelizumab, ofatumumab and "third generation" anti-CD20 monoclonals are in development.

title: Dirucotide
text: immune response genes. It does not seem to be effective in patients with other gene variants. The drug is exclusively licensed by "BioMS Medical Corp"., a Canadian-based biotechnology company. "BioMS Medical" received clearance from the Food & Drug Administration (FDA) to initiate a phase III clinical trial, named MAESTRO-03, for secondary progressive MS patients in January 2007. An additional Phase III clinical trial for dirucotide, MAESTRO-01, is being undertaken in Canada and Europe. In September 2008, the drug was granted FDA fast-track for approval. A phase II trial of Dirucotide as a potential therapy for relapsing-remitting multiple sclerosis (RRMS), MINDSET-01,

title: Ofatumumab
text: Ofatumumab Ofatumumab (trade name Arzerra, also known as HuMax-CD20) is a fully human monoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating follicular lymphoma, diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia. This makes ofatumumab the first marketing application for an antibody produced by Genmab, as well as the first human