Statement: Biogen Receives Favorable Decision from European Patent Office on Patent Related to TECFIDERA® (dimethyl fumarate)

On October 25, 2024, the European Patent Office (EPO) Opposition Division upheld the validity of Biogen patent EP 2 653 873, which expires in February 2028 and claims treating relapsing remitting multiple sclerosis using dimethyl fumarate dosed at 480 mg per day, which is the European Medicines Agency (EMA) recommended maintenance dose for TECFIDERA® (dimethyl fumarate). This decision may be appealed to the EPO’s Technical Boards of Appeal and the validity of this patent is also subject to challenge in individual European Union (EU) countries.

TECFIDERA is expected to have regulatory marketing protection in the EU until February 3, 2025.

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 76 countries, and more than 600,000 patients have been treated with it, representing more than 1,400,000 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
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

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References:

1. Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of December 31, 2023.