Lemtrada approval?

Anyone know what is up with Lemtrada approval based on FDA "needing" more info...are they pushing back offers/hiring date as I am currently interviewing.

 

Where did you hear that? I haven't read such thing on any public domain.

 

Well?

 

Bump

 

Google lemtrada under news. Comments from the FDA are very negative.

 

http://www.fiercepharma.com/story/fda-staffers-throw-cold-water-sanofis-lemtrada-hopes/2013-11-08

If you're a drug developer, which 6 words do you never, ever want to see in an FDA review of a potential new product? The 6 words applied to Sanofi's ($SNY) multiple sclerosis treatment Lemtrada: "serious and potentially fatal safety issues."

In advance of next week's advisory panel meeting on the drug, FDA staff reviewers flagged links between Lemtrada and autoimmune disorders, thyroid disease, cancer and other maladies. That means the drug is too risky to approve unless it really works, and works well, the agency staffers said.

Unfortunately for Lemtrada, reviewers weren't convinced of its efficacy, either. The staff review questioned whether Sanofi's trial data was adequate to prove that the drug works. Together with the safety questions, that could be a death knell for Lemtrada in the U.S.--and the U.S. would be Sanofi's most lucrative market for the drug.



Read more: FDA staffers throw cold water on Sanofi's Lemtrada hopes - FiercePharma http://www.fiercepharma.com/story/fda-staffers-throw-cold-water-sanofis-lemtrada-hopes/2013-11-08#ixzz2k4qy6Qgq
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External candidate here. We all knew the offer was contingent on this meeting. Shocking news because it was approved in Europe. Unless you are unemployed, you just stay at your job if this approval gets rejected or delayed. My only question is until what period of time is this contingent offer good for. So if the FDA asks for more trials the offer is null. But if they delay approval for months etc, can we change our minds and declined an offer we already accepted?

 

Of coarse you can change your mind....It may be a good idea at this point.

 

Different scenario-committee approves but demands a heavier REMs and it'll be obvious this will be an even harder sell but we get our letter for a start date- are we legally bound to have to start with them?? I'm ready to call them and tell them I don't want it even though I sent in my paperwork

 

It's called quitting. At will employment!

 

The odds of FDA approval went from about 90% yesterday to about 25% today. Reason is that Sanofi didn't do their trials properly, so the efficacy data is far too weak to offset the well-known safety concerns. For those unaware, there is a stock (ticker GCVRZ) which is entirely tied to the performance of Lemtrada. I owned this stock until today and have followed it closely, which is how I know. I would definitely NOT quit any job in hopes of one selling Lemtrada in the US, at least until the FDA meeting next Wednesday.

 

After scanning that 370 page document I don't see how the committee would suggest approval.
What surprises me is the fact it's a surprise to Genzyme. I thought they were confident on approval based on communication with the FDA. According to the document the FDA had suggested a different design but Genzyme went ahead and stuck to the design. When the FDA suggests, a company should listen. I was unaware if all the melanomas, cancers etc. and yes I know of those CRVs. When Sanofi started buying them back this summer I thought it was based on confidence of approval.

 

Any insight from internal people? What are the plans for either a pos or a neg opinion from the committee? If pos, do you plan on going thru with the offers or waiting until the actual FDA decision?

 

advisory board recommended approval today 14-0

 

Still waiting for the final FDA approval on the 27th before they bring on the new hires

 

It was approved for cancer why wouldn't it be approved for MS? Only need 8 infusions.
AEs are well known. The FDA will be doing a disservice to MS patients if the deny them this therapy. Yes, it will be REMs and black box. Monotherpy and Hail Mary.

 

FDA will approve crack for pain relief before they approve this turd with a suit on.

 

They basically have approved crack for pain. It's called opioids. Kills a lot of people.

 

7 days

 

Any news?