Alemtuzumab: a refuse to file letter from the FDA

Cambridge, MA – August 27, 2012 – Genzyme has announced that it has received a “Refuse to File” letter from the U.S. Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of LEMTRADA™ (alemtuzumab) as a treatment for relapsing multiple sclerosis. After collaborative consultations with the FDA, the agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the application. The FDA has not requested additional data or further studies. Genzyme will work with the FDA over the coming weeks to resubmit the application as soon as possible.

“We have had constructive dialogue with the FDA, and we are very confident in our ability to address the agency’s request and resubmit rapidly,” said David Meeker, President and CEO, Genzyme. The company’s marketing authorization application submitted to the European Medicines Agency has been accepted and the review process is underway. Genzyme is developing LEMTRADA in MS in collaboration with Bayer HealthCare.

Read the press release on the Genzyme website

“Déjà vu; I have been here before! This is what happened to oral cladribine. It put back the cladribine application 6  months in the US and delayed the FDA decision until after the EMA decision. I believe the negative EMA decision affected the FDA’s decision. Let’s hope that Alemtuzumab does not go the same way as oral cladribine.”

9 thoughts on “Alemtuzumab: a refuse to file letter from the FDA”

  1. Isn't a negative EMA decision most unlikely this time? There haven't been any cancers in the trials

  2. The Alemtuzumab "issue" is gaining speed. It has made the news in most of the german newspapers and has also been mentioned on a more or less important german newsblog.I see a shitstorm a'brewing….

  3. By this time, tysabri wa already producing it's first cases of PML and nothing like that so far with alemtuzumab. I can't believe the EMA won't approve it on the basis of the evidence that has been produced so far. Why doesn't the MS Soc put something in the press about the alem issue? As lobbyists they are useless

    1. Why don't we start a lobby via this blog? It seems a good place for us MSers to come together. Any takers?

    2. This is not a good idea for three reasons. (1) This blog is relatively small (~1400 hits per day, (3) we have no idea how many of these hits are from MSers and (2) we have conflicts of interest in that the Royal London Hospital has been trial sites of the CARE-MS 1 & 2 studies. The MS Society, MS Trust and would be more appropriate organisations for a MSer-led lobby. They are bigger and don't have conflicts of interests. We can help by preparing a post and putting a link on our blog to the lobby site! Just let me know when you have it set-up.

  4. Somebody is in trouble; getting the format right for an FDA submission is very basic. This simple error will delay Lemtrada getting to the US market by at least 6 months. Poor people with MS expecting the drug sooner rather than later. Another issue is if the EMA gives Lemtrada a second-line label the FDA may do the same. They say that every day of delay in getting a blockbuster to market costs the company concerned between $10-17M. A 180 day delay is costing Genzyme something between S1.8 and $3 billion in sales. This is a very expensive mistake that could become more expensive if Lemtrada gets a second-line label as a result of the FDA following the EMA.

  5. The whole Alemtuzumab story is already on wikipedia. Prof G wanted to know how CCSVI got so big. Look and learn….

  6. How did CCSVI get so big…Social Media, rubbish media creating a hype and unscruplious docs who will sell people unproven treatments for profit.This is the history of fad treatments in MS, stem cells, goat serum etc, etc, etc,They all have the same MO. At the centre are people without adequate treatment for their condition willing to try anything and unscruplious medics who are happy to liberate people of their cash. (I know in the US neuros in the main stream medicine can be accussed of this also, but at least there is an evidence base behind the treatments)If CSSVI does not prove to be correct these Doctors should be tracked down and struck-off in my opinion, especially within the EU. If it does prove right…..ditto…..because they are profiteering

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