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Home » Uncategorized » Biogen Idec and Elan have filed for approval for Tysabri (Natalizumab) as first-line treatment for relapsing forms of MS in anti-JC virus (JCV) antibody negative patients

Biogen Idec and Elan have filed for approval for Tysabri (Natalizumab) as first-line treatment for relapsing forms of MS in anti-JC virus (JCV) antibody negative patients



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Tysabri (Natalizumab)

CAS number 189261-10-7 
ATC code L04AA23
DrugBank DB00108
17 JAN 2013
Biogen Idec and Elan have filed for approval for Tysabri (Natalizumab) as first-line treatment for relapsing forms of MS in anti-JC virus (JCV) antibody negative patients. The PDUFA date for the sBLA to expand Tysabri’s label is in 2H-2013. Currently Tysabri is  used in patients who are not responding to or who are unable to tolerate an alternative therapy.  From an efficacy perspective, Tysabri is the most potent among all existing treatment options.
MS Patients with anti-JCV antibody positive status treated with Tysabri are at an increased risk of developing progressive multifocal leukoencephalopathy (PML). Earlier this year, both the U.S. and EU updated Tysabri labels to reflect the same.
According to Biogen and Elan, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider Tysabri early in the course of treatment, regardless of the level of disease activity or prior treatment history

Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. Natalizumab is used in the treatment of multiple sclerosis and Crohn’s disease. It is co-marketed by Biogen Idec and Élan as Tysabri, and was previously namedAntegren. Natalizumab is administered by intravenous infusion every 28 days. The drug is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. Natalizumab has proven effective in treating the symptoms of both diseases, preventing relapse, vision loss, cognitive decline and significantly improving quality of life in people with multiple sclerosis, as well as increasing rates of remission and preventing relapse in Crohn’s disease.

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 It was subsequently withdrawn from the market by its manufacturer after it was linked with three cases of the rare neurological condition progressive multifocal leukoencephalopathy(PML)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, anotherimmunosuppressive 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. As of June 2009, ten cases of PML were known. However, twenty-four cases of PML had been reported since its reintroduction by October 2009, showing a sharp rise in the number of fatalities and prompting a review of the chemical for human use by the European Medicines Agency.[1][2][3] By January 2010, 31 cases of PML were attributed to natalizumab.[4] The FDA did not withdraw the drug from the market because its clinical benefits outweigh the risks involved.[5] In the European Union, it has been approved for human use only for the treatment of multiple sclerosis and only then as a 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.[6]

  1. Meeting highlights from the Committee for Medicinal Products for Human Use” (pdf). European Medicines Agency. 2009-10-22. Retrieved 2010-08-31.
  2. Hirschler, B; Cowell D (2009-10-29). “EU agency reports 24th case of Tysabri infection”Reuters. Retrieved 2010-08-31.
  3. Clarke T; Orlofsky S; Von Ahn L (2009-06-29). “Biogen reports 10th case of PML brain infection”Reuters. Retrieved 2010-08-31.
  4. Jeffrey, S (2010-02-05). “PML Risk Increases With Repeated Natalizumab Infusions: FDA”Medscape. Retrieved 2010-08-31.
  5. Hitti, M (2008-08-01). “MS Drug Tysabri Tied to Brain Infection”WebMD. Retrieved 2010-08-31.
  6.  “Biogen Idec testing Tysabri as a cancer treatment”The Boston Globe. 2008-09-05. Retrieved 2008-09-05.

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DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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