Genzyme's Alemtuzumab Disappears as a Leukemia Drug to be Reborn as a Multiple Sclerosis Drug

Alemtuzumab is playing Phoenix and being reborn from its ashes:

_**Once a powerful drug against Leukemia, [1,2], Alemtuzumab is being repackaged as a Multiple Sclerosis drug [3].**_ The motivation to withdraw Alemtuzumab  as a  Leukemia treatment is not clear.

According to the Blood Journal [1]: "…Alemtuzumab delivered intravenously, but not subcutaneously, remains the treatment of choice for previously untreated T-PLL (T-cell prolymphocytic leukemia)…"

According to the Leukemia Journal[2] : "…We conclude that alemtuzumab looks promising for the therapy of acute lymphoid leukemia,.."

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Administration by Infusion

_**So why pull Alemtuzumab from the Leukemia treatment market**_ [4]? Just because it is a promising. although almost too potent drug in Multiple Sclerosis immunosuppression [5-7]?

Quoting Neurotherapeutics [5]: "…Alemtuzumab is an effective therapy for early relapsing-remitting MS, offering disability improvement at least up to 5 years after treatment. Its use requires careful monitoring so that potentially serious side effects can be treated early and effectively…" It is not clear to me why the two uses, as a Leukemia AND MS drug cannot coexist.

Some cynical minds claim that Sanofi can sell the MS drug at a much higher profit than at the existing price of Alemtuzumab under its leukemia drug name Campath [7]

The MS Research Journal quotes the NIH, and says: "…alemtuzumab will [only] be available through a named patient access programme for cancer and transplant indications…" Named patient access program?

According to the  Pharmavoice [8] "…Named Patient Program begins when a physician contacts the company developing the drug. Such requests are made on behalf of an individual patient and that's really why we use the term Named Patient Program…"

_The irony is that such restricted access programs are usually to obtain drugs before they have full approval…_ So, if the Sanofi motivation is really just higher profit, (which we hope it is not…), do government bodies such as the FDA have a responsibility or duty to exert pressure on Sanofi to protect the needs of the Leukemia patients?

_**We are not usually fond of such interventions on the markets, but this, if proven true, such corporate behavior would be over the top!**_

_**Sources:**_

1. [Bloodjournal](http://bloodjournal.hematologylibrary.org/content/118/22/5799.abstract) ; "Alemtuzumab therapy in T-cell prolymphocytic leukemia" ; Sep 2001
2. Leukemia ; "
3. [BusinessWire](http://www.businesswire.com/news/home/20120611006439/en/Genzyme-Submits-Applications-FDA-EMA-Approval-LEMTRADA%E2%84%A2) ; ""Genzyme Submits Applications to FDA and EMA for Approval of LEMTRADA™ (alemtuzumab) for Multiple Sclerosis" ; June 2012
4. [PharmaTimes](http://www.pharmatimes.com/Article/12-08-21/Sanofi_withdraws_Campath_in_US_and_EU.aspx)  ; "Sanofi withdraws Campath in US and EU" ; Aug 2012
5. [Neurotherapeutics](http://www.ncbi.nlm.nih.gov/pubmed/23184314)  ; "Alemtuzumab Therapy for Multiple Sclerosis." ; Nov 201
6. [BBC](http://www.bbc.co.uk/news/health-20151891) ; "Multiple sclerosis: New drug 'most effective'" ; Nov 2012
7. [Multiple Sclerosis Research](http://multiple-sclerosis-research.blogspot.com/2012/08/discontinuation-of-licensed-supplies-of.html) ; Aug 2012
8. [Pharmavoice](http://www.pharmavoice.com/content/industryevents/transcriptIDIS_Wisener.html) ; ""…Leveraging Expanded Access and Named-Patient Programs.." ; March 2010

URL: http://www.medinewsdigest.com/?p=5729