Serelaxin is a Disaster

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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.
 








Anonymous said:
Told you!

European regulators hand Novartis a big setback on a top blockbuster prospect

January 24, 2014 | By John Carroll

European regulators handed Novartis a major setback in its quest to gain an approval for serelaxin, one of the pharma giant's top blockbuster prospects which earned "breakthrough" status at the FDA. The European Medicines Agency's Committee for Medicinal Products for Human Use rejected Novartis' application, calling out the development team for failing to demonstrate quick relief for heart disease in the first 24 hours, failing to demonstrate the significance of the benefit over 5 days and calling into question the data that were presented.

The CHMP's recommendations are generally followed by the European Commission when it makes the final decision on marketing. Now if Novartis ($NVS) wants to win an approval in Europe, it will likely have to present data from another study, derailing the company's marketing timetable. The stinging rejection in Europe could spell trouble in the U.S. as well, where the FDA has the drug under review.

Novartis is known for aggressive trial execution for a large slate of pipeline projects but typically does a poor job communicating with investors and reporters--particularly when the news is bad. Today, though, with a top drug hopeful in peril after a critical review, the pharma giant was in top form, putting R&D execs on the phone with analysts to outline Plan B: Shooting for conditional OK in Europe in the second quarter and then leveraging new data for a full approval, when it could expect to ramp up sales in line with expectations.
"We would expect sales to be modest initially, but then really take off after the second clinical trial proves its mortality benefit," noted Novartis' pharma chief David Epstein, according to a report from Reuters.

In late 2012 the pharma giant cited serelaxin as Exhibit A in making the case to investors that it has the late-stage drugs that will be needed to arrest a slide in sales revenue. The drug--a synthetic version of the hormone relaxin that aids pregnant women--helped improve shortness of breath among patients over 5 days. But the drug missed other endpoints, raising fears among analysts that an approval this year could simply set up a more critical review process among payers.

That's particularly bleak news for a drug that was expected to play a material role in filling the gaps that will be left when Diovan and Gleevec lose patent protection. Several analysts had estimated peak sales at more than $1 billion. But not everyone was sold on the data.
"This is only a modest negative in our view," wrote Bernstein's Tim Anderson. "While Novartis management has been bullish on the drug's prospects, investors have generally taken a more cautious view because the data seemed mixed. Novartis continues to describe the drug as showing a clear mortality benefit, but independent heart failure experts have been more lukewarm because the mortality benefit described was not part of the primary or secondary endpoints."

The EMA's Committee for Medicinal Products for Human Use was blunt in its assessment:
"The Committee noted that the study results did not demonstrate a benefit for short-term relief of dyspnea over up to 24 hours, and although some benefit was shown over 5 days it was not clear how this was of clinical relevance. Furthermore, the Committee had concerns about the way the effectiveness of the medicine in the study had been analyzed. The results included calculated values for a number of patients who had died or had required additional treatment for worsening symptoms and whose actual data were not used. In addition, the CHMP questioned whether differences in the background treatment given to patients in the two study groups may have influenced the results. Since only one main study was included in the application, further studies would be needed to confirm the effectiveness of Reasanz (serelaxin) in the treatment of acute heart failure."
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Can someone explain what's the problem? Management?
 




Anonymous said:
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.
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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
 




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




Anonymous said:
The FDA and EMA have differed on opinions. I know there have been several examples, but top of mind is are tanswernew 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.
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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.
 




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




















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!
 








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
 








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