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May 12, 2014

Top 18 Best-Selling Drugs Launched in 2013

These newcomers are on the rise.

Top 18 Best-Selling Drugs Launched in 2013

Find out which new drugs made the most money since their 2013 debut. [© Saharrr - Fotolia.com]

  • 2013 wasn’t technically a blockbuster year for new drugs, since no treatment launched last year reached the magic billion-dollar benchmark. But one drug came close, and at least two other 2013 launches started strongly enough to suggest that they may become blockbusters this year.

    Overall, sales figures for 2013 launches were a tale of two tiers—over $100 million by at least four new drugs, and another 14 launches whose sales fell around the same range as the new drugs launched during 2012. That adds up to just 18 best sellers. The number would have been at least 20, but companies declined to disclose sales for several additional 2013 launches—Johnson & Johnson’s Invokana for type 2 diabetes in adults; Kynamro, marketed by Sanofi and Isis Pharmaceuticals for a rare form of high cholesterol, homozygous familial hypercholesterolemia; Bayer HealthCare’s pulmonary hypertension drug Adempas; and two Boehringer Ingelheim launches, Striverdi Respimat for chronic obstructive pulmonary disease (COPD) and Gilotrif/Giotrif, the company’s first entry into the oncology market.

    Why the silence? Isis’ COO/CFO Lynne Parshall told analysts in March of this year that Kynamro sales were off to a “slow start,” with both companies saying that more reps would be hired to jumpstart sales. J&J has included Invokana as one of several new products that it said enjoyed “strong sales” last year, without furnishing a figure. The closest to an actual number is one widely-quoted estimate, by Wells Fargo analyst Lawrence Biegelson, projected that Invokana would generate $122 million in first-year 2013 sales.

    J&J was more forthcoming with one of the soon-to-be blockbusters, the chronic hepatitis C treatment Olysio/Sovriad. In April, J&J trumpeted its $354 million in first-quarter 2014 sales—and also tucked inside its quarterly earnings announcement that the drug racked up global 2013 sales of $23 million.

    Another new drug that could not make the list is the Biogen Idec/Genentech (Roche) drug Gazyva (obinutuzumab), an anti-CD20 monoclonal antibody as is the companies' Rituxan (rituximab). While Roche reported CHF 3 million ($3.369 million) for Gazyva, Biogen Idec reported only a combined $1.1 billion in sales for both drugs in 2013, not breaking out Gazyva sales.

    Following is a list of 18 drugs launched in 2013, and whose companies furnished 2013 sales information, allowing for ranking. Drugs are listed by trade name (U.S./Europe where it varies), generic name, 2013 sales, company or companies marketing the drug, indication, and date of FDA and/or European Commission approval. 

  • #18. Lemtrada (alemtuzumab)

    2013 sales: $2.773 million (€2 million)10

    Marketer(s): Genzyme, a Sanofi Company, and Bayer HealthCare

    Indication(s): Monoclonal antibody that selectively targets CD52, indicated for relapsing remitting multiple sclerosis (RRMS) in adults, with active disease defined by clinical or imaging features

    Date of FDA approval: On April 30, 2014, Sanofi released data linking patients treated three years with Lemtrada to a slowing of brain atrophy and reductions in new MS lesions, following FDA rejection on December 30, 2013

    Date of European Commission approval: September 17, 201310

  • #17. Osphena (ospemifene)

    2013 Sales: $4.887 million (¥ 500 million)

    Marketer(s): Shionogi

    Indication(s): Estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause

    Date of FDA approval: February 27, 2013

    European Medicines Agency accepted its marketing authorization application on March 13, 2013.

  • #16. Opsumit (macitentan)

    2013 Sales: $5.688 million (CHF 5 million)

    Marketer(s): Actelion Pharmaceuticals

    Indication(s): Endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression

    Date of FDA approval: October 22, 2013

    Date of European Commission approval: December 20, 2013

  • #15. Breo Ellipta/ Relvar Ellipta (fluticasone furoate and vilanterol inhalation [FF/VI] powder)

    2013 Sales: $13.492 million (£8 million)

    Marketer(s): GlaxoSmithKline and Theravance2

    Indication(s): Combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated in U.S. only for long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Indicated in Europe for COPD in adults with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy, and additionally for regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.

    Date of FDA approval: Of COPD indication, May 10, 2013

    Date of European Commission approval: Of COPD and asthma indications, November 18, 2013

  • #14. Imbruvica (ibrutinib)

    2013 Sales: $13.6 million3

    Marketer(s): Pharmacyclics and Janssen Biotech (Johnson & Johnson)

    Indication(s): Kinase inhibitor indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and for chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

    Dates of FDA approval: For MCL indication, November 13, 2013; for CLL indication, February 12, 2014.

    Seeking European Commission approval for adults with relapsed or refractory CLL / small lymphocytic leukaemia (SLL) or relapsed or refractory MCL.3

  • #13. Mekinist (trametinib)

    2013 Sales: $16.865 million (£10 million)

    Marketer(s): GlaxoSmithKline

    Indication(s): Kinase inhibitor indicated as a single agent and in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test; indicated in combination with Tafinlar (dabrafenib) for patients with advanced melanoma that is unresectable or metastatic

    Date of FDA approval: May 29, 2013; FDA approval of Mekinist-Tafinlar combination came on January 10, 2014

    European Commission approval: September 2, 2013

  • #12. Olysio / Sovriad (simeprevir)

    2013 Sales: $23 million4

    Marketer(s): Johnson & Johnson

    Indication(s): Hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen

    Date of FDA approval: November 22, 2013; positive opinion by European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) March 20, 2014

    European Commission decision expected later this year.

  • #11. Tafinlar (dabrafenib)

    2013 sales: $26.984 million (£16 million)

    Marketer(s): GlaxoSmithKline

    Indication(s): Kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test; indicated in combination with Mekinist (trametinib) for patients with advanced melanoma that is unresectable or metastatic

    Date of FDA approval: May 29, 2013; FDA approval of Tafinlar-Mekinist combination came on January 10, 2014

    Date of European Commission approval: September 2, 2013

  • #10. Gattex / Revestive (teduglutide [rDNA origin]) for injection

    2013 Sales: $31.8 million

    Marketer(s): NPS Pharmaceuticals

    Indication(s): Glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adult patients with Short Bowel Syndrome who are dependent on parenteral support

    Date of FDA approval: December 21, 2012

    Date of European Commission approval: August 30, 20125

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