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February 18, 2014

Top 10 Multiple Sclerosis Drugs

Find out which MS drugs brought in the most money last year.

Top 10 Multiple Sclerosis Drugs

In MS, the central nervous system is attacked, damaging the myelin covers of nerve cells. [© iceteastock - Fotolia.com]

  • 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

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