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Biogen Idec’s ‘Plegridy’ therapy for multiple sclerosis delayed by FDA

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[Update: The Plegridy's phase III ADVANCE study showed "less than 1% of all patients in the study discontinued due to flu-like symptoms" and if those symptoms did appear, "97% of those episodes were considered mild to moderate."]

Biogen Idec announced last year their Plegridy for multiple sclerosis (MS) had met all endpoints and had submitted it for U.S. Food and Drug Administration (FDA) approval with the understanding they would be able to launch it near the middle of 2014.

Tuesday’s regulatory news, however, has Biogen releasing a statement saying that although “the FDA didn’t ask for additional studies”; they have “extended the review process by three months.”

Scientists had combined interferon beta-1a, the pharmacological ingredient that is contained in relapsing-remitting MS therapies (RRMS), with the pegylation process so those who use shot therapies, subcutaneous injection therapies, can have less frequent dosing schedules.

[Get free email subscription to Lima Multiple Sclerosis Examiner to receive news and updates [click here].

PEGylation is a procedure that attaches polyethylene glycol chains to another molecule that has been around since the 1970’s due to Frank F. Davis, a professor of biochemistry at Rutgers University.

Professor Davis was able to show the attachment of an “inert and hydrophilic polymer might extend blood life and control immunogenicity of the proteins” and this method is what is used in Plegridy 40 years later.

Interferon injections are hard for patients to endure as they can lead, more often than not, to major flu-like symptoms for up to two days after injection and studies have shown patients will delay or sometimes quit treatment due to the severity of it.

The drug showed better treatment effectiveness when used every two weeks as opposed to the every four weeks, both having been done through clinical studies.

*video above: "New Multiple Sclerosis Drugs Deliver Side Effects" (information on shot-therapies and pill-therapies for MS.)

For more info: for those who live in Lima, Ohio, the Northwestern Ohio MS Chapter can be reached at: 401 Tomahawk Drive, Maumee, OH at (419) 897-7263. They are located approximately an hour and a half from Lima, Ohio and 45 minutes from Findlay, Ohio. For directions please click here at Google Maps

Multiple Sclerosis Community Support:

  • MS World ~ “We've come together from around the world to help each other cope with the challenges of living with Multiple Sclerosis.”
  • Patients like Me ~ “Our Promise PatientsLikeMe is committed to putting patients first. We do this by providing a better, more effective way for you to share your real-world health experiences in order to help yourself, other patients like you and organizations that focus on your conditions.”
  • Med Help, Multiple Sclerosis ~ “Today, MedHelp empowers over 12 million people each month to take control over their health and find answers to their medical questions. MedHelp, a privately-funded company, has over 16 years of accumulated information from doctors and other patients across hundreds of conditions. In addition, MedHelp has long-standing partnerships with the top medical institutions such as the Cleveland Clinic, National Jewish, Partners Health, and Mount Sinai. MedHelp's audience, archives, and partnerships make it a unique health destination on the Internet.”

Sources: http://www.biogenidec.com/Files/Filer/VPR/press_materials/aan2013_EN/FactSheet-PEG-IFN-v4-12Mar2013-FINAL-US.pdf; http://www.reuters.com/article/2014/03/18/biogen-fda-multiplesclerosis-idUSL3N0MF32I20140318; http://www.sciencedirect.com/science/article/pii/S0169409X02000212, Frank F. Davis; http://www.medicalnewstoday.com/articles/257962.php

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