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SERELAXIN DEAD !!!!!!!!!!!!!!!!!!!!!

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FDA Rules

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Thank God this drain won't be imposed on the US healthcare system
BRAVO FDA !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Novartis Heart Drug Shouldn’t Be Approved, FDA Staff Says
By Anna Edney Mar 25, 2014 9:14 AM ET

Novartis AG (NOVN)’s experimental heart failure medication shouldn’t be approved for sale, U.S. regulators said, potentially dealing a blow to the company’s plan to build a portfolio of cardiac therapies around the drug.

“There is insufficient evidence to support” Novartis’s claim the drug, serelaxin, helps prevent worsening of the disease that causes the heart to malfunction, Food and Drug Administration staff said today in a document posted online. The FDA on March 27 will convene advisers to consider serelaxin.
 




UPDATE 1-FDA staff review recommends against Novartis heart failure drug

Tue Mar 25, 2014 8:58am EDT

(Reuters) - A drug to treat acute heart failure made by Novartis AG should not be approved because there is insufficient evidence to show it improves symptoms, according to an initial review by the U.S. Food and Drug Administration.

The review, posted on the FDA's website on Tuesday, comes two days ahead of a meeting of outside advisors who will make their own recommendation on whether the drug should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

Acute heart failure is a medical emergency in which patients become short of breath as the heart struggles to pump blood and fluid around the body. The drug, serelaxin, is a genetically engineered hormone that relaxes blood vessels and eases the burden on the heart.

"We recommend that serelaxin not be approved at this time because there is insufficient evidence to support the proposed indication to "improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure," the reviewers said. "We did not identify any significant safety concerns precluding approval."

About 5 million people in the United States are living with chronic heart failure, a progressive weakening of the heart, according to Novartis. About 1 million are hospitalized with episodes of acute heart failure, and about 22 percent of patients who are hospitalized die within a year.

Novartis filed for approval of serelaxin based on a single study which showed that when given alongside standard treatment, it alleviated shortness of breath by slowing the rate of worsening heart failure following hospitalization.

Results showed the drug reduced deaths by 37 percent compared with patients in the control group after six months of treatment.

The FDA said it generally requires evidence from two independent trials to show an improvement in symptoms. Moreover, the reviewers said that the data did not capture symptoms of acute heart failure other than dyspnea, or shortness of breath, such as cough, choking, fatigue and anxiety.

"Therefore, the current evidence does not support a broad claim related to the symptoms of acute heart failure," they said, adding that the trial results "do not provide persuasive evidence of an effect on dyspnea".
 




FDA review slams Novartis's case for beleaguered heart drug serelaxin
March 25, 2014 | By John Carroll

One of Novartis's top late-stage drug prospects is in deep trouble. In advance of an upcoming advisory committee meeting, the FDA in-house review says point blank that the application for the heart drug serelaxin should be rejected as the pharma giant has yet to provide the decisive data on efficacy needed to green-light the therapy.

The review wastes no time in cutting to the chase. Novartis failed to back up the proposed indication on acute heart failure, didn't conduct a second trial--or design the single study to provide the equivalent data load of two studies--to confirm the drug's effect on dyspnea, and didn't actually engineer the pivotal trial to back up its double-edged claims on easing symptoms and changing the rate of heart failure in any case.
 




In late 2012 the pharma giant cited serelaxin as Exhibit A in making the case to investors that it has the late-stage drugs 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, the company asserted. 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 showdown with payers may have to wait, though.

Novartis is now 0 for 2 on the regulatory front. Back in January the European Medicines Agency's Committee for Medicinal Products for Human Use rejected Novartis' application for serelaxin, 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. Novartis immediately shifted tactics, though, saying it would shoot for a conditional approval. That option, though, is increasingly looking like a long shot, at best.

The FDA review makes for an interesting critique of the development team which designed and executed the study for this drug, finding fault with what the reviewer determined was a badly flawed trial.

The FDA wrote: "The results of RELAX-AHF were driven by worsening heart failure that could be easily medically managed with small increases in doses of IV diuretics. In fact, the mean difference in IV furosemide doses between treatment groups over the 5-day assessment period was 60 mg and the median difference was 20 mg (higher in the placebo group). The small difference in diuretic use provides some evidence of drug activity but it is a small treatment effect seen in one trial."

"Even if one were to accept the results of RELAX-AHF at face value with the prespecified worsening heart failure imputation method, the clinical meaningfulness of the difference in VAS dyspnea scores is questionable. A 447.7 mm-hr mean difference in VAS-AUC change from baseline between treatment groups translates into a an average difference between treatment groups of ~ 4 mm on the 100 mm VAS scale."

The FDA advisory committee meets on Thursday
 








































hey jesus- nice job- Why don't you take all your external hires and exit stage left -
karma is a bitch they say, so open wide and take a big slurp of the shit soup.

So I guess the company's future is now riding on the mighty Derm franchise that has been at NVS a whopping 6 months!! If it looks like shit and smells like shit, guess what? It's shit!
 




I kind of hope the company goes right along with it. I'm bitter and I can't believe how such poor management in a 10 year period could drive a really good company into the ground!
 




I was contacted by a recruiter about this position a month ago since I currently sell in the cardiology space, have solid relationships and have won some national awards. Thank god I didn't waste my time.

What happened to Novartis?!?
 
















I'm excited to hear corporate's spin tomorrow. How many times will they say this was "unexpected" and how much they are "committed to the brand." They may even paint a picture of a poor heart failure patient and the unmet need they are attempting to fill.
 




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