Our therapies

We develop medicines for serious medical conditions with few or no treatment options. Every day, we work to bring patients better outcomes and advance their standard of care. 

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Multiple Sclerosis 

AVONEX® 

AVONEX® (interferon beta-1a) has been available for more than 18 years as one of the first prescribed interferon therapies for the treatment of relapsing forms of MS worldwide. AVONEX is approved for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

The most common side effects associated with AVONEX MS treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.

AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Rare cases of anaphylaxis have been reported.

AVONEX Website

AVONEX Full Prescribing Information

AVONEX Medication Guide

FAMPYRA®

FAMPYRA® (prolonged-release fampridine tablets) is a treatment indicated to improve walking in adult patients with multiple sclerosis (MS). Biogen has a license from Acorda Therapeutics, Inc. to develop and commercialize FAMPYRA in all markets outside the United States. In the U.S., this prolonged-release fampridine tablet formulation was developed and is being marketed by Acorda under the name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

FAMPYRA is the first treatment to both address the unmet medical need of walking improvement in adults living with MS, and demonstrate clinical efficacy in adults with MS. FAMPYRA can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs.

In clinical trials, patients responding to FAMPYRA had an average increase in walking speed of 25 percent and FAMPRYA was shown to provide a clinically meaningful improvement in walking.

The highest incidence of adverse reactions identified from placebo-controlled trials in MS patients with FAMPYRA, given at the recommended dose, was urinary tract infection (in approximately 12% of patients), although infection was often not proven by culture. Adverse drug reactions identified were mainly divided between neurological disorders, such as insomnia, balance disorder, dizziness, paraesthesia, headache and gastrointestinal disorders including nausea, dyspepsia and constipation. In post-marketing experience, there have been reports of seizure. Confounding factors may have contributed to the occurrence of seizure in some patients.

For further information on FAMPYRA in your country please click here

For further information about AMPYRA in the U.S. please go to www.ampyra.com.

 

PLEGRIDY™

PLEGRIDY™ (peginterferon beta-1a) is approved for the treatment of relapsing forms of MS with a dosing schedule of once every two weeks.

PLEGRIDY contains interferon beta-1a, which is pegylated to extend its half-life. The most common adverse reactions associated with PLEGRIDY treatment are injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus and arthralgia. PLEGRIDY can cause serious side effects, including serious allergic reactions, injection site reactions, heart problems including congestive heart failure, autoimmune diseases, blood problems and changes in your blood tests, and seizures. 

PLEGRIDY Website

PLEGRIDY Full Prescribing Information

 

TECFIDERA®

TECFIDERA® (dimethyl fumarate) is an oral therapy approved in the United States for the treatment of relapsing multiple sclerosis, which is the most common form of the disease. TECFIDERA has been proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile. Tecfidera is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA and can cause anaphylaxis and angioedema, progressive multifocal leukoencephalopathy (PML), lymphopenia and flushing. The most common adverse reactions for TECFIDERA were flushing, mostly mild to moderate in nature, and GI events (i.e., diarrhea, nausea, and abdominal pain). These events are most common at the start of therapy and usually decrease over time. Because TECFIDERA may decrease lymphocyte counts, a CBC including lymphocyte count should be obtained before initiating TECFIDERA, after 6 months, and every 6 to 12 months thereafter.

TECFIDERA is also approved in Canada, Australia, Switzerland and the European Union.

TECFIDERA Website

TECFIDERA Full Prescribing Information

TECFIDERA Patient Information

Vermont Pharmaceutical Price Disclosure - Long Form

Vermont Pharmaceutical Price Disclosure - Short Form

TYSABRI®

TYSABRI® (natalizumab) is a treatment approved for relapsing forms of MS in adults in the United States and highly active relapsing-remitting MS in adults in the European Union.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses. Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in patients treated with TYSABRI in the postmarketing setting. A list of adverse events can be found in the full TYSABRI product labeling for each country where it is approved

TYSABRI Website

TYSABRI Full Prescribing Information

TYSABRI Medication Guide

Multiple Sclerosis

With over 30 years of clinical excellence in MS, Biogen is a leader in multiple sclerosis (MS) research. Biogen continues its commitment to patients through ongoing research, solutions and services to support unmet needs in the management of MS. Biogen currently has the broadest MS portfolio in the industry with products that help treat across the spectrum of relapsing forms of MS. Through affordability programs, we are committed to continuing to improve access to products for patients who need them.

MS Support Resources

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Hemophilia

ALPROLIX®

ALPROLIX® (Coagulation Factor IX [Recombinant], Fc Fusion Protein) is the first recombinant, clotting factor IX therapy with prolonged circulation. In the United States, it is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B. ALPROLIX is not indicated for immune tolerance induction therapy, which is a treatment for people with inhibitors. ALPROLIX is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.

ALPROLIX is developed by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). It is believed that this enables ALPROLIX to use a naturally occurring pathway to prolong the time therapy remains in the body. Biogen is the only company to apply Fc fusion to the treatment of hemophilia. 

ALPROLIX is contraindicated in individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to ALPROLIX or its components.

Common adverse reactions (incidence of greater than or equal to 1 percent) from the clinical study were headache and oral paresthesia (an abnormal sensation in the mouth).

ALPROLIX is also approved in Canada, Australia and Japan.

For complete U.S. prescribing information, please visit ALPROLIX.com.

ALPROLIX Website

ALPROLIX Full Prescribing Information

ALPROLIX Instructions for Use

ELOCTATE®

ELOCTATE® (Antihemophilic Factor [Recombinant], Fc Fusion Protein) is the first recombinant factor VIII therapy with prolonged circulation in the body. In the United States, ELOCTATE is approved for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A. ELOCTATE is not indicated for the treatment of a bleeding disorder called von Willebrand disease.

ELOCTATE is the only treatment for hemophilia A to reduce the frequency of bleeding episodes with prophylactic (protective) infusions starting at every four days, which can be adjusted based on clinical response to every three to five days. The therapy offers people with hemophilia A the potential to extend the interval between prophylactic infusions.

ELOCTATE is developed by fusing B-domain deleted factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). This was designed to enable ELOCTATE to use a naturally occurring pathway to prolong the time therapy remains in the body. Biogen is the only company to apply Fc fusion to the treatment of hemophilia.

ELOCTATE is contraindicated in people who have had life-threatening hypersensitivity reactions, including anaphylaxis, to the therapy.

Common adverse reactions (incidence of greater than or equal to 1 percent) from the registrational Phase 3 clinical study were arthralgia (joint pain) and malaise (general discomfort).

ELOCTATE is also approved in Australia, Canada and Japan.

For complete U.S. prescribing information, please visit ELOCTATE.com.

ELOCTATE Website

ELOCTATE Full Prescribing Information

ELOCTATE Instructions for Use

Hemophilia

Biogen is deeply committed to transforming hemophilia management through innovative treatments. We have combined our long history of scientific and clinical excellence and our expertise in manufacturing large-scale biologics to develop and deliver clinically meaningful therapies. Biogen is the first company to provide prolonged circulating factor therapies for hemophilia A and hemophilia B. These therapies represent the first major advancements in hemophilia treatment in almost two decades. At Biogen, our commitment to the hemophilia community extends to supporting access to therapy, including humanitarian donations and providing comprehensive patient access and assistance programs shaped by community input. 

Hemophilia Support Resources

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Partnered Therapies

GAZYVA®

GAZYVA® (obinutuzumab), injection for intravenous infusion, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). The FDA granted GAZYVA breakthrough therapy designation. GAZYVA, formerly known as GA101, was approved by the FDA in November 2013.

CLL is one of the most common forms of blood cancer. Most cases of CLL (95 percent) start in white blood cells called B cells that have a protein called CD20 on their surface.

GAZYVA can cause side effects that can become serious or life-threatening, including hepatitis B reactivation, progressive multifocal leukoencephalopathy (PML), infusion reactions, tumor lysis syndrome (TLS), infections and low blood counts. The most common side effects of GAZYVA are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough and muscle and joint pain. These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist. GAZYVA is available by prescription only.

Please see the full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information.

GAZYVA website

GAZYVA Full Prescribing Information

RITUXAN®

RITUXAN® (rituximab) is approved for treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) as a single agent; for previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens; for previously untreated follicular,

CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy; and for the treatment of nonprogressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy.

RITUXAN is also approved for use in combination with methotrexate (MTX) for reducing signs and symptoms and to slow the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

RITUXAN is also approved in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).

RITUXAN has been associated with fatal infusion reactions, tumor lysis syndrome, severe mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation with related fulminant hepatitis and other serious viral infections, cardiovascular events, renal toxicity and bowel obstruction and perforation.

The most common adverse events in previous trials of RITUXAN in RA were infusion-related symptoms, affecting 32% of patients receiving RITUXAN vs. 23% receiving placebo during the first infusion. The incidence of infusion reactions decreased with each subsequent infusion. The most common reactions included fever, chills/rigor, nausea, asthenia and headache. These reactions generally have resolved with slowing or interruption of the infusion and with supportive care.

RITUXAN Website

RITUXAN Full Prescribing Information & Medication Guide

Partnered Therapies

We collaborate with Genentech, a member of the Roche Group, on the development and commercialization of RITUXAN®. In addition, in the United States we collaborate with Genentech on GAZYVA®. The Roche Group maintains sole responsibility for the development, manufacturing and commercialization of GAZYVA in the U.S.

Partnered Therapies Support Resources

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