European regulators squelch Multaq review for Sanofi's big day?

So, the EMA puts out a big press release saying:

The Committee is holding this additional meeting outside of its normal schedule because the new information on the safety of Multaq only became available shortly before the Committee's last plenary meeting of 18-21 July 2011. The assessors have now analysed the new data in depth, as well as additional information requested from the marketing-authorisation holder, in preparation for Friday's meeting...

After Friday's meeting, the Agency will announce the outcome of the Committee's discussions and explain the next steps.


But it's the eve of Sanofi's big investor party? Not a great time to pull your new heart drug?

Then we get: Never mind, it can wait after all:

The Committee for Medicinal Products for Human Use (CHMP) met on Friday 2 September 2011 to discuss the ongoing benefit-risk review of the anti-arrhythmic medicine Multaq (dronedarone).

The Committee discussed all of the currently available data on the risk of cardiovascular problems, liver and lung injuries reported with the use of Multaq in order to prepare for its next scheduled meeting of 19-22 September 2011, when it expects to finalise its review.

Really?? That's not what they said yesterday

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/09/news_detail_001332.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1


Hmmmmmmm.

 

Not really surprised with this new announcement. I know that in the US the FDA is still receiving PALLAS study materials from study sites. There is so much to look at, that we will still be hearing about PALLAS patients for some time. With this in mind, the ESC was quick to approve Multaq, they placed it in a favorable status on the AFib guidelines and now with the PALLAS negative outcomes as well as other life threatening issues, they have mud on their face and are back tracking. France's National Formulary decision on Multaq was held up as well so that they could see the full review for Multaq and decide on whether they will reimburse it.

Multaq may not get pulled, but it will get another Labeling update (probably Black Box Warning) on permanent AFib. Sanofi had budget Multaq for 300M in 2012, revised that to 275M in first quarter and now is down to 245M for the rest of the year. If it gets a BBW from the FDA, then you can revise that again to 200M and call it a day and a wash out for Multaq.

The next decision will be, does Sanofi need 650 Reps selling Multaq?

 

Excellent post... I have heard the same revised figure for Multaq, 245 mil, which clearly wont happen after we got a B Box. Any Multaq rep I talk to is thinking pretty much the same. Do you need 650 of us? In fact there is probably less at the moment as many went to BI and other companies. So off the top say there are 600 left. Even then its too much, esp with the other rumor being we are done promoting Plavix as of Jan of 012. You can only place so many of us in open diabetes positions and then again that division is at least 1000 reps too large. My Lantus reps in my area are always tripping over each other. Unless Sanofi thinks they are going to co-market something soon I cant imagine them not cutting. Even the Apidra only sales force is a joke. They should have done that when they launched. But then again what do we know in the field?