FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis

Patient Expert

Patients living with multiple sclerosis in the US may choose among fourteen FDA-approved disease-modifying therapies (DMTs) to slow down the long-term progression of the disease by reducing relapses, number of lesions, and accumulation of physical disability.

Many of the DMTs detailed below are prescribed for people with relapsing forms of MS, including relapsing-remitting MS, as well as secondary-progressive MS and progressive-relapsing MS in those people still having relapses. Select DMTs have also been approved to delay a second exacerbation in people who have been diagnosed with clinically isolated syndrome (CIS).

So far, no DMTs have proven to be effective in progressive forms of MS without relapses. However, the B-cell depleting medication, ocrelizumab, was found to be effective in both relapsing and progressive forms of MS. The MS community eagerly anticipates FDA approval of ocrelizumab in 2016.

Disease-modifying therapies (DMTs) for MS

  • Oral therapies: Aubagio, Gilenya, Tecfidera
  • Injectable therapies: Avonex, Betaseron, Copaxone, Extavia, Glatopa, Plegridy, Rebif
  • Infusion therapies: Lemtrada, Novantrone, Ocrevus, Tysabri
  • Approved for relapsing forms of MS: Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Glatopa, Lemtrada, Novantrone, Ocrevus, Plegridy, Rebif, Tecfidera, Tysabri
  • Approved for clinically isolated syndrome (CIS): Avonex, Betaseron, Copaxone, Extavia
  • Approved for primary progressive MS: Ocrevus
  • Approved for worsening MS or select forms of progressive MS: Novantrone
  • Generic medication: Glatopa

Aubagio®

Aubagio (teriflunomide, 7 mg and 14 mg; pyrimidine synthesis inhibitor) is taken once daily by mouth for relapsing forms of MS; approved in 2012. Made by Sanofi-Genzyme; websites: aubagio.com, msonetoone.com

Avonex®

Avonex (interferon beta-1a, 30 mcg/.5 mL) is taken once weekly by intramuscular injection for CIS and relapsing forms of MS; approved in 1996; auto-injector and dose titration available. Made by Biogen; websites: avonex.com, abovems.com

Betaseron®

Betaseron (interferon beta-1b, 0.25 mg/mL) is taken every other day by subcutaneous injection for CIS and relapsing forms of MS; approved in 1993. Solution must be mixed before injection. Made by Bayer HealthCare; website: betaseron.com

Copaxone®

Copaxone (glatiramer acetate, 20 mg/mL and 40 mg/mL; synthetic polypeptide) is taken by subcutaneous injection every day (20 mg dose) or three days each week (40 mg dose) for CIS and relapsing forms of MS; approved in 1996; auto-injector available. Made by Teva Neuroscience; websites: copaxone.com, sharedsolutions.com

Extavia®

Extavia (interferon beta-1b, 0.25 mg/mL) is taken every other day by subcutaneous injection for CIS and relapsing forms of MS; approved in 2009. Solution must be mixed before injection; dose titration available. Made by Novartis; website: extavia.com

Gilenya®

Gilenya (fingolimod, 0.5 mg; sphingosine 1-phosphate receptor modulator) is taken once every day by mouth for relapsing forms of MS; approved in 2010. Made by Novartis; website: gilenya.com

Glatopa™

Glatopa (glatiramer acetate – generic equivalent of Copaxone 20mg dose) is taken by subcutaneous injection every day (20 mg dose) for relapsing forms of MS; approved in 2015. Glatopa is not interchangeable with the 40mg dose of Copaxone. Made by Novartis; website: glatopa.com

Lemtrada™

Lemtrada (alemtuzumab, 12 mg; CD52 monoclonal antibody) is delivered by intravenous infusion on five consecutive days, followed by another three consecutive days one year later, for relapsing forms of MS and generally reserved for people with MS who have failed other treatments; approved in 2014. Made by Sanofi-Genzyme; website: lemtrada.com

Novantrone®

Novantrone (mitoxantrone, 140 mg; antineoplastic anthracenedione) is delivered by intravenous infusion once every 3 months with a lifetime maximum limit of 8-12 doses over 2-3 years for worsening relapsing-remitting MS, progressive-relapsing MS, or secondary-progressive MS; approved in 2000. Available as generic drug since 2006. Previously made by EMD Serono/Immunex Corp.

Ocrevus™

Ocrevus (ocrelizumab, 300 mg/10 mL; CD20 monoclonal antibody) is delivered by intravenous infusion every six months, for relapsing or primary progressive MS; approved in 2017. Made by Genentech; website: ocrevus.com

Plegridy™

Plegridy (peginterferon beta-1a, 0.125 mg/.5 mL) is taken every 14 days by subcutaneous injection for relapsing forms of MS;approved in 2014; auto-injector available. Made by Biogen; websites: plegridy.com, abovems.com

Rebif®

Rebif (interferon beta-1a, 22 mcg/.5 mL and 44 mcg/.5 mL) is taken three days each week by subcutaneous injection for relapsing forms of MS: approved in 2002; auto-injector and dose titration pack available. Made by EMD Serono/Pfizer; websites: rebif.com, mslifelines.com

Tecfidera®

Tecfidera (dimethyl fumarate, 240 mg; Nrf2 activator) is taken twice daily by mouth for relapsing forms of MS; approved in 2013. Made by Biogen; websites: tecfidera.com, abovems.com

Tysabri®

Tysabri (natalizumab, 300 mg; α4β1-integrin monoclonal antibody) is delivered by intravenous infusion once every four weeks at a registered infusion center for relapsing forms of MS; approved in 2006. Must not be combined with other disease-modifying therapies. Made by Biogen; websites: tysabri.com, abovems.com

If one DMT doesn’t work for you, or is intolerable, discuss other options with your neurologist.

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Updated April 2017