Skip to content

What Is The Most Expensive Orphan Drug In The World ?

December 21, 2012

The most expensive drug in the world in 2010, is orphan drug Soliris (Eculizumab) from Alexion Pharmaceuticals.

Soliris in the US

- FDA Orphan Drug Designation (ODD) for paroxysmal nocturnal hemoglobinuria (PNH) on August 20, 2003

- FDA Approval for PNH orphan indication & exclusivity start date is March 16, 2007

ODD for atypical Hemolytic Uremic Syndrome (aHUS) on April 29, 2009

- FDA Approval for aHUS orphan indication & exclusivity start date is September 23, 2011

ODD for treatment of Shiga-Toxin on October 18, 2011

- Costs > $409,000/annually/patient

- Generates $295 million in sales in 2009; $541 million in sales in 2010

- There are 4,000 – 6,000 PNH patients in the US.

Soliris is approved for patients with PNH in the US (2007), European Union (2007), Japan (2010), and other territories. It is the first and only treatment indicated for PNH . Soliris is also approved as the first and only treatment for patients with aHUS, another ultra-rare disease, in the US (September 2011) and in the European Union (November 2011).

References

MedicalBillingAndCoding.org February 6, 2012 Article titled, “The 11 Most Expensive Medicines in America”

Orphan Druganaut August 15, 2012 Blog Post titled, “Is there a relationship between the most expensive US Medicines & orphan drugs?”

PNH Foundation

Thomson Reuters 2012 Report titled, “The Economic Power of Orphan Drugs”.

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

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

Join 1,819 other followers

%d bloggers like this: