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Good News For Pfizer’s Orphan Drug Bosulif (Bosutinib) In Europe

January 18, 2013

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on January 17, 2013, adopts a positive opinion, recommending a conditional marketing authhorization for Pfizer’s orphan drug Bosulif (Bosutinib) for Chronic Leukemia (CML).  Bosutinib receives orphan designation from the European Commission (EC) on August 4, 2010, for CML.

Pfizer receives FDA approval on September 4, 2012, for orphan drug Bosulif (Bosutinib) for CML. Pfizer receives on February 24, 2009, FDA Orphan Drug Designation (ODD) for Bosutinib for CML.

Per a September 2012 article in, a Pfizer spokesperson says that “the drug will cost less than $8,200/month”/patient in the US. In other words, treatment will cost approximately $98,400/patient/year. Also per FierceBiotech, “Bosulif is the 3rd new medicine from Pfizer Oncology’s pipeline to be approved by the FDA in just 13 months ….”.


EMA June 2011 COMP Summary Opinion For Orphan Designation for Bosutinib for CML

FiercePharma January 18, 2013 article titled, “Pfizer’s Bosulif set for greater sales with EMA approval”

FDA September 4, 2012 News Release

The National CML Society

Pfizer September 4, 2012 Press Release

Pfizer January 18, 2013 Press Release.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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