Following is a list of 10 FDA-approved drugs for patients with multiple sclerosis—nine of 10 disease-modifying agents authorized by the agency, plus a drug whose indication is specific to MS patients—ranked by their 2013 sales, as reported by the companies that market them. Drugs are listed by name, sponsor(s), dosage information, mechanism of action, indication, and sales data.
Last year’s best-selling MS drug, Copaxone, will have the challenge in 2014 of sustaining its U.S. sales in the face of competition from several generic versions of glatiramer. Awaiting FDA approval at deadline to sell generic glatiramer once the first patents expire in May are Novartis and partner Momenta Pharmaceuticals, as well as Natco Pharma and partner Mylan. Both teams have prevailed against Teva in patent litigation.
Last month Teva highlighted a study it commissioned and funded, showing differences in gene expression linked to key therapeutic effects between Copaxone and Natco’s glatiramer. Teva insists it acted more from patient safety that from a desire to protect a lucrative drug franchise that has accounted for 20% of total sales and about half of total earnings. Teva also hopes to beat back the generic challengers with a new dosage that won FDA approval last month. The new dosage allows patients to take 40 mg three times weekly, rather than the current regimen of 20 mg daily. The company has said it plans to convert 57% of current Copaxone patients to the new dosage.
As well as Copaxone has performed for Teva, Biogen Idec generated more in sales from MS drugs last year, with three of its own products and a fourth product partnered (with Acorda Therapeutics) in the top 10, accounting for a combined $5.563 billion in sales. Next most prominent on the list is Novartis, with two drugs combining for just over $2 billion, followed by three pharma giants and two biotechs, each with $1 billion or less in sales.
#10. Extavia (interferon beta-1b)
Sponsor/Developer: Novartis
Dosage strength, form, and frequency: Recommended dose is 0.25 mg injected subcutaneously every other day. Generally, start at .0625 mg (0.25 mL) subcutaneously every other day, and increase over a six week period to 0.25 mg (1 mL) every other day
Mechanism of action: Unknown
Indication: Relapsing forms of MS to reduce the frequency of clinical exacerbations
2013 sales: $159 million
#9. Aubagio (teriflunomide)
Sponsor/Developer: Genzyme (Sanofi)
Dosage strength, form, and frequency: 7 mg and 14 mg tablets, once-daily, with or without food
Mechanism of action: Pyrimidine synthesis inhibitor
Indication: Relapsing forms of MS
2013 sales: About $226 million (€166 million)1
#8. Ampyra (dalfampridine) / Fampyra
Sponsor/Developer: Acorda Therapeutics and Biogen Idec
Dosage form and strength: 10 mg tablets
Mechanism of action: Potassium channel blocker
Indication: Improve walking in patients with MS
2013 sales: $302.301 million2
#7. Rebif (interferon beta-1a)
Sponsor/Developer: EMD Serono and Pfizer
Dosage strength, form, and frequency: 22 mcg and 44 mcg by injection three times per week. Rebif should be administered, if possible, at the same time (preferably late afternoon or evening) on the same three days, at least 48 hours apart each week. Generally, patients should be started at 20% of the prescribed dose three times per week and increased over a four-week period to the targeted dose, either 22 or 44 mcg three times per week
Mechanism of action: Unknown
Indication: Relapsing forms of MS, to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability.
2013 Sales: About $622 million (€460 million) through September 30, 20133,4
#6. Tecfidera (dimethyl fumarate)
Sponsor/Developer: Biogen Idec
Dosage strength, form, and frequency: Starting dose: 120 mg twice a day, orally, for seven days, followed by maintenance dose after seven days: 240 mg twice a day, orally. Capsules must be swallowed whole and intact. Tecfidera can be taken with or without food.
Mechanism of action: Unknown
Indication: Relapsing forms of MS
2013 Sales: $876 million
#5. Betaseron (Betaferon; Interferon beta-1b)
Sponsor/Developer: Bayer HealthCare
Dosage strength, form, and frequency: Recommended dose is 0.25 mg via injection every other day. Generally, patients are advised to start at 0.0625 mg (0.25 mL) via injection every other day, and increase over a six-week period to 0.25 mg (1 mL) every other day
Mechanism of action: Unknown
Indication: Relapsing forms of MS, to reduce the frequency of clinical exacerbations
2013 sales: $1.05 billion (€779 million) as of September 30, 20135
#4. Tysabri (natalizumab)
Sponsor/Developer: Biogen Idec6
Dosage strength, form, and frequency: 300 mg infused intravenously over approximately one hour, every four weeks
Mechanism of action: Binds to the α4-subunit of α4β1 and α4β7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the α4-mediated adhesion of leukocytes to their counter-receptor(s).
Indication: Adults with relapsing forms of MS
2013 sales: $1.67 billion7
#3. Gilenya (fingolimod)
Sponsor/Developer: Novartis
Dosage strength, form, and frequency: Recommended dose: 0.5 mg orally once daily, with or without food
Mechanism of action: Metabolized into Fingolimod-phosphate, a sphingosine 1-phosphate receptor modulator that binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism of action on MS is unknown but may involve reduction of lymphocyte migration into the central nervous system.
Indication: Relapsing forms of MS, to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability
2013 sales: $1.9 billion
#2. Avonex (interferon beta-1a)
Sponsor/Developer: Biogen Idec
Dosage strength, form, and frequency: 30 micrograms once a week is recommended. To reduce the incidence and severity of flu-like symptoms that may occur when initiating Avonex therapy at a dose of 30 micrograms, Avonex may be started at a dose of 7.5 micrograms and the dose may be increased by 7.5 micrograms each week for the next three weeks until the recommended dose of 30 micrograms is achieved.
Mechanism of action: Unknown
Indication: Relapsing forms of MS, to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations
2013 Sales: $3 billion8
#1. Copaxone (glatiramer acetate)
Sponsor/Developer: Teva
Dosage strength, form, and frequency: 20 mg/mL daily by injection; 40 mg/mL three times per week by injection (9)
Mechanism of action: Not fully understood; believed to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS.
Indication: Relapsing forms of MS
2013 sales: $4.328 billion
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