Future of Bystolic?!?!?!?!?!?

FDA staff against wider approval of Forest drug

Thursday, Jan 07, 2010 1:9PM UTC

WASHINGTON (Reuters) - A Forest Laboratories Inc hypertension drug should not be approved for people with heart failure, a U.S. drug reviewer said in a preliminary analysis released on Thursday.

The Food and Drug Administration staff memo, prepared for an agency advisory panel, said "the totality of evidence is not convincing to support a claim for treatment of heart failure" with the drug, Bystolic.

"Approval is not recommended" for the heart failure use, FDA reviewer Shona Pendse wrote.

Forest already sells the drug for treating high blood pressure.

An FDA panel of outside experts is scheduled to review data on the heart failure use at a public meeting on Monday. The panel will hear from FDA reviewers and the company before making recommendations.

The FDA usually follows panel advice when making final approval decisions.

In a separate summary, Forest said Bystolic "offers a new evidence-based treatment option with a favorable benefit risk profile" for heart failure patients.

The FDA posted the staff and company summaries at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm196556.htm.

 

This is a devastating blow to Forest. We all know that the CHF indication was our ace in the hole, now we run the risk of losing our hypertensive business. Docs are using bystolic solely for atenolol and metoprolol failures and now that we can't even establish efficacy and indications where these garbage products have for years - what a joke. Time to dust off the resume!!!!!!!

 

this really is a huge blow to the company, we will definitely face layoffs now or corporate is going to have to get yet another late stage product to get approved and promote asap

 

Good riddance your company is full of a bunch of fools and idiots who are losers and are promoting drugs that they have no idea about. I hope Forest implodes and all of your idiot reps are on the soup line or selling cars which is what they were doing before coming to Forest. What a joke this company is.

 

Just means we need more data. Not that it doesn't work.

 

how long is that going to take? we needed this win NOW before lex goes generic

I agree, Bystolic must work for CHF, look at the SENIORS trial vs coreg

unfort the obama run FDA is going to put pharma out of business one way or another

 

Bystolic is a joke of a drug ! It can not even compare to coreg in any way and the fda agrees. Lying reps promoting off label for the longest time. The company has been marketing this drug by lying about vasodialating properties trying to be like coreg. But no worries CHF is such a small piece of the pie its not gonna matter.. Keep lying about your novel bb and lying about getting bp drops with once a day dosing( that's a joke and evryone knows it-

 

This news serves you guys right. Everyone knows you talk off label about the CHF indication, or "when we get the CHF indication...". I wonder how your docs are going to feel when they hear about this. Have fun putting out that fire and thanks so much for providing us with even more ammunition!!!

 

I work here and i agree with above poster....this company is full of a bunch of fools and idiots.......AMATEUR HOUR!!!!!!!!!

 

In turning down Bystolic, the FDA would have a hard time explaining why 71 other countries have approved Bystolic for CHF. No other BB has even attempted to show morbity /mortality efficacy in 75 year olds with higher EFs. I know of two reviews that found that very elderly patients do not get great benefit from BBs in heart failure. That is why Bystolic is apporved in other countries. The FDA is accused of being pharma's lapdog and this is how they please the media. The review committee will approve Bystolic and the FDA will do the right thing and go with the review committee's decision.

 

The Seniors trial shows much better efficacy in women than in men (just looking at the HR's for the primary endpoint). If they don't get the CHF indication as it has been applied for, would they resubmit the CHF application for use only in women?

 

Look this drug is crap. You guys talk about vasodilatation which is crap and if you did have significant vasodilatation you would have a CHF indication. Crawl under a rock because this drug is total crap and now I understand why you say Bystolic is not the same as Coreg because Coreg is indicated in CHF and your drug is total crap!!!!!!!

 

The only thing that Bystolic is vasodilating is Forest's pocketbook. Hopefully there will be a billion dollar class action law suit because of your lackey's false promotions.

 

its done: decision is over....no chf indication!

 

I think the fact that Forest tried to get the indication based almost entirely on a European trial is what shot them in the foot. The FDA is way too conservative and they want pharma to spend the millions of dollars on large outcome trials on their own soil if they're even going to contemplate approval. Forest is not (and never has been) the type of company that will invest hundreds of millions into long-term outcomes studies...we wait for the NIH or a European agency (as in SENIORS) to do them for us. This strategy ceases to work when you have an ultra-conservative FDA who pander to the media. Forest needs to put the money into Bystolic's research - its a great drug and clinically different. I think we are just scratching the surface when we talk about it as an antihypertensive.

 

My opinion of Forest is that they are a very intelligent company. Why not test the waters and submit data that was already done to show Bystolics efficacy in CHF. Just because the panel voted no does not mean that Bystolic will not work for CHF either. If Forest wants to pursue the indication now they will have to conduct the studies here in the US, plain and simple. The hypertension market is still the biggest money maker, while CHF is pretty small in the grand view of things. Other than that, CHF shouldnt be our concern as no one should be promoting it in any fashion anyway.

 

Good to see that sales compliance is still on CP. Thanks for the reminder about not talking about CHF. And remember lets do it the right way!

 

Because testing the waters further destroys our credibility? If this was a truly novel product, then why not conduct outcomes studies to prove it? We had the warning letter first (for "testing the waters" with our marketing materials) and now the non-approval for this indication. We are trying to separate ourselves from the competition and the only thing that seems to separate is that we can't get an indication! I guarantee that we will see a slide in RX post non-approval, especially amongst Cardiologists. I'd rather have never submitted vs. tried and failed because instead of selling on our hypertension indication I am going to be diverting questions about this for the next 3 months.

 

So true. Just like the warning letter, now this is all docs are going to want to talk about.

 

time to sign a new co-promote is NOW-this Byst ship will be a slow leak over the next few months-Forest will not sink tens of millions of bucks into long term studies for a drug that will surely not recoup these investments