European Patent Office Grants Patent Related to TECFIDERA® (Dimethyl Fumarate)
Biogen Inc. (Nasdaq: BIIB) announced that the European Patent Office granted a patent for TECFIDERA (dimethyl fumarate), expiring in February 2028. This patent supports the approved dosing regimen of 480mg per day for treating multiple sclerosis, as recommended by the European Medicines Agency. TECFIDERA is the most prescribed oral medication for relapsing forms of MS globally, with over 560,000 patients treated, accumulating more than 1.1 million patient-years of exposure. Patent details are expected to be published in the European Patent Bulletin soon.
- Patent granted for TECFIDERA, expiring in 2028, supporting its approved dosing.
- TECFIDERA is the most prescribed oral medication for relapsing MS globally.
- Over 560,000 patients have been treated with TECFIDERA, demonstrating significant market demand.
- Serious side effects associated with TECFIDERA, including anaphylaxis and potential neurological risks.
- Concerns over lymphopenia and its uncertain role in adverse events.
- Patent covers approved dosing regimen for TECFIDERA and expires in 2028
CAMBRIDGE, Mass., June 21, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Patent Office has granted a patent that expires in February 2028 related to TECFIDERA® (dimethyl fumarate). The patent, EP 2 653 873, is directed to treating multiple sclerosis using dimethyl fumarate dosed at 480mg per day, which is the European Medicines Agency (EMA) recommended maintenance dose for TECFIDERA.
Patent EP 2 653 873 was granted from a divisional patent application of European Patent No. 2 137 537 and includes amended claims, which the European Patent Office Examining Division determined were allowable under the relevant provisions of the European Patent Convention.
Biogen expects the patent to be published in the European Patent Bulletin in the coming weeks.
About TECFIDERA® (dimethyl fumarate)
TECFIDERA, a treatment for relapsing forms of multiple sclerosis (MS) in adults, is the most prescribed oral medication for relapsing MS in the world and has been shown to reduce the rate of MS relapses, slow the progression of disability and impact the number of MS brain lesions, while demonstrating a well-characterized safety profile in people with relapsing forms of MS. TECFIDERA is approved in 69 countries, and more than 560,000 patients have been treated with it, representing more than 1,100,000 patient-years of exposure across clinical trial use and patients prescribed TECFIDERA.1
TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Serious side effects include anaphylaxis and angioedema, and cases of progressive multifocal leukoencephalopathy, a rare opportunistic viral infection of the brain which has been associated with death or severe disability, have been seen with TECFIDERA patients in the setting of prolonged lymphopenia although the role of lymphopenia in these cases is uncertain. Other serious side effects include a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. In clinical trials, the most common adverse events associated with TECFIDERA were flushing, abdominal pain, diarrhea and nausea.
Please click here for Important Safety Information and full Prescribing Information, including Patient Information for TECFIDERA in the U.S., or visit your respective country’s product website.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and developed the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing one of the industry’s most diversified pipelines in neuroscience that will transform the standard of care for patients in several areas of high unmet need.
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References:
- Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of December 31, 2021.
| MEDIA CONTACT: Ashleigh Koss + 1 908 205 2572 public.affairs@biogen.com | INVESTOR CONTACT: Mike Hencke +1 781 464 2442 IR@biogen.com | |
FAQ
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