Serelaxin is a Disaster

Has there ever been a time when the FDA has approved a drug that the EU has rejected? I can't think of one. In fact, its usually the other way around. Look at Galvus, approved in the EU but rejected by the FDA. I think Serelaxin is in deep doo doo.

 

Correct! EMEA is usually not as rigorous as FDA, so Serelaxin is screwed.

 

Can someone explain what's the problem? Management?

 

don't worry the Japanese trials will show it stops heart failure , eliminates MI's , reduces aging & provides hello kitty purses for girls , pokemon cards for boys

 

The FDA and EMA have differed on opinions. I know there have been several examples, but top of mind is are the new diet drugs. EMA said no, FDA said yes.

February 13th is a big day in the US for serelaxin. I think the advisory panel will recommend serelaxin for approval (or at least it should) because the data from Relax AHF, although a mixed bag of results is better than anything out there for AHF and the FDA approved Natrecoe on significantly less data. On the other hand, many felt burned by what happened with Natrecor with the ASCEND trial, so the FDA may raise the bar significantly for new therapies for AHF. The outcome of the Feb 13 advisory panel is going to be a role of the dice for serelaxin.

 

I hope this drug gets approved. Its a game change er for people with HF.
however, I couple years ago in a town hall, during q&a. The panel was ask about the number of reps that would sell this drug. The answer was 70. So good for the company, but means nothing to the reps current ly with nvs.

 

Game Changer? LMAO! Another placebo like nothing. Freaking corporate stooge.
Go back to bed. The EMA knows a lot better than you.

 

Xeljanz

 

Dont worry - NVS has jesus leal leading the charge!

HE did a great job with Arcapta now that was a game changer

Go Jesus!

 

What luck, FDA Advisory panel gets postponed due to weather. Ugh.

 

Gives them more time to look at the data and scratch their head wondering what Novartis was thinking? Then again, all they have to do is look at Ilaris.

 

company has lost all credibility in the CV field in the unlikely event the fda in a lapse of sanity approves it, it will be DOA no matter how much $marketing$ is done
this dog makes aliskren look like atorvastatin

 

Time to cut some dead branches in IHC. What an embarrassment, when it was so obvious from the outset given trial design and data. Novartis must have some kool-aid as the pattern of continued FDA spanking repeats itself again!

 

Did you go home yet Tim & Co. ?

 

don't worry - if the studies were bad, we'll find another disease that this will work in. got too much money invested to let it go without trying again...hopefully with a better approach to study design

 

great strategy- throw crap against wall and see if it will stick!