FDA-Approved Disease-Modifying Therapies for MS
by Lisa Emrich Patient Advocate
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 active secondary-progressive MS, and primary-progressive MS in those people having relapses. Select DMTs have also been approved to delay a second exacerbation in people who have been diagnosed with clinically isolated syndrome (CIS).
Research has demonstrated only one DMT to be effective in progressive forms of MS without relapses. Ocrelizumab which was FDA approved in 2017, a B-cell depleting medication, ocrelizumab, was found to be effective in both relapsing and progressive forms of MS.
Disease-modifying therapies (DMTs) for MS:
Oral therapies: Aubagio, Gilenya, Mavenclad, Mayzent, Tecfidera
Injectable therapies: Avonex, Betaseron, Copaxone, Extavia, Glatopa, Glatiramer Acetate, Plegridy, Rebif
Infusion therapies: Lemtrada, Novantrone, Ocrevus, Tysabri
Approved for relapsing forms of MS: Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Glatopa, Glatiramer Acetate, Lemtrada, Mavenclad, Mayzent, Novantrone, Ocrevus, Plegridy, Rebif, Tecfidera, Tysabri
Approved for clinically isolated syndrome (CIS): Avonex, Betaseron, Copaxone, Extavia, Mayzent
Approved for primary progressive MS: Ocrevus
Approved for active secondary progressive MS: Mavenclad, Mayzent
Approved for worsening MS or select forms of progressive MS: Novantrone
Generic medication: Glatopa, Glatiramer Acetate
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
Glatiramer Acetate Injection
Glatiramer acetate injection – a generic equivalent of Copaxone — is taken by subcutaneous injection three times per week (40 mg/mL dose) or daily (20 mg/mL dose) for relapsing forms of MS; approved in 2017; auto-injector available. Made by Mylan; website: glatirameracetate.com
Glatopa™
Glatopa (glatiramer acetate – generic equivalent of Copaxone 20mg dose — is taken by subcutaneous injection every day (20 mg/mL dose) or three times per week (40 mg/mL dose) for relapsing forms of MS; approved in 2015 and 2018, respectively. Glatopa is not interchangeable with the 40 mg/mL dose of Copaxone. Made by Sandoz/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
Mavenclad®
Mavenclad (cladribine, 10 mg; purine antimetabolite) is taken orally with a cumulative dosage of 3.5 mg/kg divided into 2 treatment courses (1.75 mg/kg per treatment course) during two courses of treatment separated by one year. Each course consists of two cycles: five consecutive days of treatment, followed by another five consecutive days of treatment one month later. It is approved for use in relapsing forms of MS and active secondary progressive MS; generally recommended for people with MS who have failed other treatments; approved in 2019. Made by EMD Serono; website: mavenclad.com
Mayzent®
Mayzent (siponimod, 0.25 mg and 2 mg; sphingosine 1-phosphate receptor modulator) is taken orally once daily after a five-day titration period. Indicated for relapsing forms of MS, including CIS, RRMS, and active secondary progressive disease; approved in 2019. Made by Novartis; website: mayzent.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.
