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Top 20 Best-Selling Drugs Approved and Launched During 2012

What new medicines are shaking things up?

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#10. Linzess™ (linaclotide)

2012 sales: $19.2 million⁹

Marketer(s): Ironwood Pharmaceuticals and Forest Laboratories

Indication(s): Irritable bowel syndrome with constipation and chronic idiopathic constipation in adults

Date of FDA approval: August 30, 2012

#9. Erivedge® (vismodegib)

2012 sales: $30.9 million (CHF 29 million)¹⁰

Marketer(s): Roche (Genentech)

Indication(s): Advanced basal cell carcinoma in adults who cannot have surgery or radiation therapy

Date of FDA approval: January 30, 2012

#8. Zaltrap® (ziv-aflibercept)

2012 sales: $32.3 million (€25 million)¹¹

Marketer(s): Sanofi and Regeneron

Indication(s): Metastatic colorectal cancer in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI) chemotherapy regimen

Date of FDA approval: August 3, 2012

Date of European Commission approval: February 5, 2013

#7. Stivarga™ (regorafenib)

2012 sales: $41.4 million (€32 million)^12,13

Marketer(s): Bayer HealthCare and Onyx Pharmaceuticals

Indication(s): Metastatic colorectal cancer in patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy

Date of FDA approval: September 27, 2012

#6. Stribild™ (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)

2012 sales: $57.536 million¹⁴

Marketer(s): Gilead Sciences

Indication(s): HIV-1 infection in adults who are antiretroviral treatment-naïve

Date of FDA approval: August 27, 2012

#5. Perjeta® (pertuzumab)

2012 sales: $59.7 million (CHF 56 million)¹⁵

Marketer(s): Roche (Genentech)

Indication(s): First-line treatment of HER2-positive metastatic breast cancer in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease, in combination with Herceptin® (trastuzumab) and docetaxel

Date of FDA approval: June 8, 2012

Date of European Commission approval: March 5, 2013

#4. Kyprolis® (carfilzomib)

2012 sales: $64 million

Marketer(s): Onyx Pharmaceuticals

Indication(s): Multiple myeloma in patients who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy

Date of FDA approval: July 20, 2012

#3. Inlyta® (axitinib)

2012 sales: $70.1 million¹⁶

Marketer(s): Pfizer

Indication(s): Advanced renal cell carcinoma after failure of one prior systemic therapy

Date of FDA approval: January 27, 2012

Date of European Commission approval: September 4, 2012

#2. Xtandi® (enzalutamide)

2012 sales: $71.5 million

Marketer(s): Medivation and Astellas Pharma

Indication(s): Metastatic, castration-resistant prostate cancer in men who have previously received treatment with docetaxel

Date of FDA approval: August 31, 2012

#1. Kalydeco™ (ivacaftor)

2012 sales: $171.6 million

Marketer(s): Vertex Pharmaceuticals

Indication(s): Cystic fibrosis (CF) in patients 6 years old and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator (CFTR) gene

Date of FDA approval: January 31, 2012

Date of European Commission approval: July 23, 2012