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

 

Not included on the list are two other MS-focused products: the remaining FDA-approved disease-modifying agent Novantrone, now sold as a generic drug by several companies that do not break out individual generic product sales; and Zanaflex, whose 2013 sales (reported by Acorda along with sales and royalty revenue it receives for an authorized generic version sold by Actavis) were too low to be ranked.

Notes:
1 Reflects mostly U.S. sales (€152 million or about $207 million) since FDA was first to approve the drug in September 2012. In August 2013, the European Commission granted marketing authorization for Aubagio indicated for adult patients with relapsing-remitting MS. Aubagio was also granted a new active substance designation, which provides 10 years of exclusivity in the EU. Western Europe accounted for €12 million or $16 million of Aubagio’s 2013 sales.
2 Includes unaudited 2013 full-year net sales of $302 million announced for Ampyra by Acorda on January 13 (formal fourth-quarter and full-year results are set to be announced February 13); and $17.301 million for all of 2013 reported for Fampyra by Biogen Idec.
3 EMD Serono is part of Merck KGaA, which is not scheduled to report fourth-quarter and full-year 2013 results until March 6.
4 Reflects only EMD Serono portion of sales. Pfizer does not break out sales for Rebif, instead combining the drug in a category that includes Spiriva, Aricept and Eliquis, as well as Enbrel sales recorded in the U.S. and Canada through October 31, 2013.
5 Bayer will report fourth-quarter and full year 2013 results on February 28.
6 In February 2013, Biogen Idec purchased Elan’s half-share of rights to Tysabri—restructuring what had been a 50–50 collaboration for the drug—for $3.25 billion, plus royalties. Tysabri was co-developed by Biogen Idec and Elan, which was acquired by Perrigo in a deal that closed December 18, 2013.
7 Global in-market sales totaled $1.67 billion, up 3% from 2012, and include total in-market sales of $958 million in the U.S. and $712 million in sales outside the U.S.
8 Includes $1.9 billion in U.S. sales and $1.1 billion in sales outside the U.S.
9 On January 28, the FDA approved a 40 mg/mL, three times per week by injection new formulation for Copaxone.

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