UPDATED: Novartis nabs early FDA approval for 'megablockbuster' Entresto

It was a hotly anticipated pipeline drug. Now, Novartis' heart failure remedy Entresto is a hot new approval. The FDA gave its blessing 6 weeks early, and now the former LCZ696 can get ready to roll.

The approval comes after Entresto aced an 8,442-patient clinical trial against a common therapy, rather than placebo. At the end of the study, patients with a particular form of heart failure were more likely to be alive and less likely to have been hospitalized than the patients taking enalapril, the current standard of care.

The data were so positive, trial investigator Dr. Milton Packer has said he'd have a hard time understanding why doctors would continue using traditional treatments. "Entresto is expected to change the management of patients with HFrEF for years to come," Packer said in a statement about Tuesday's approval.

As for payers, they'll have a hard time refusing to cover it, Bernstein analyst Tim Anderson said in a Wednesday investor note--even though it's priced "on the higher end" of expectations at $12.50 per pill. Discounting won't be a big a factor, either, Anderson figures. "[T]he company is not likely going to have to discount the product much off of its [wholesale price] in the absence of direct competition, and given the strength of the data," he wrote.   

Novartis pharma chief David Epstein

Of the almost 6 million Americans with heart failure, about half have the reduced ejection fraction form that's targeted by Entresto, Novartis ($NVS) says. That means millions of potential patients for a drug Novartis pharma chief David Epstein has called its "most exciting launch" in years.

The drug's survival advantage--a 20% decrease in heart-related death, the trial found--coupled with a large patient population has analysts predicting megablockbuster sales. Some have predicted as much as $10 billion a year--though north of $5 billion is a more oft-quoted figure--and consensus estimates put sales at $3.73 billion by 2019.

"[M]illions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital," Epstein said in a statement. "We recognize our responsibility to ensure Entresto reaches US patients and prescribers as soon as possible and will begin shipping in the US in the coming week."

- read the Novartis release

Special Reports: Pharma's top 10 M&A deals of 2014's first half -GlaxoSmithKline/Novartis | Top 15 late-stage blockbusters in the pipeline -LCZ696

Editor's note: This story was updated with pricing information and analyst comments.