Things are looking not-so-positive for Swiss-based pharmaceutical company Novartis. After a lackluster debut of its Entresto (sacubitril and valsartan) heart failure drug, its much-touted serelaxin has failed to clear late-stage clinical trials.
Novartis' acute heart failure drug serelaxin was promoted by the company as the next big thing in addressing the ailment. However, the drug flopped in the clinical trial as it is unable to slow down the progression of the disease. It is also ineffective in reducing cardiovascular deaths as claimed.
In 2014, the drug underwent a similar fate when both the U.S. Food and Drug Administration and the European regulators dismissed it. Novartis, however, was optimistic that it could provide enough evidence of serelaxin or RLX030's positive effects, which would alter the decision of the administrative bodies.
However, on March 22, Novartis confirmed that serelaxin had failed its global RELAX-AHF-2 phase III trial.
"We are disappointed this study did not confirm the efficacy of RLX030 in acute heart failure, especially given the urgent need for effective new treatments for this condition," said Vas Narasimhan, the company's chief medical officer.
Following the announcement, Novartis' shares fell by 2.2 percent.
Serelaxin Fails In RELAX-AHF-2 Phase 3 Trial
Serelaxin did not receive the green signal from the regulators as it failed its RELAX-AHF-2 phase 3 trial. This is basically the test in which the value, security, and acceptability are evaluated.
The test involves prescribing the drug to patients suffering from acute heart failure. This is followed by a monitoring process where it is recorded whether the subjects experience an improvement or not.
Acute heart failure is a severe condition and the main cause of hospitalization for people above the age of 65. RLX030 was designed by Novartis to relax blood vessels in a bid to relieve the burden on the heart.
Novartis' Plans: What Now?
Following the expiry of the patent rights for Diovan in 2012, which was a heart failure medicine from Novartis, the company was looking to launch serelaxin as the replacement product directed at AHF patients.
It was predicted that this drug would bring in revenues upwards of 2 billion Swiss francs (approximately $2.01 billion) by 2020. The announcement of trial failure will most likely hit Novartis hard as evidenced by the drop in its share prices.
However, Narasimhan is optimistic and shared that Novartis will persevere to analyze the data in detail. This would help the company not only gain a better understanding, but also help the drug maker evaluate the future course of action for the program.
With this rejection, only 12 new drugs are in the pipeline from the drug maker. According to analysts, the failure of serelaxin would compel Novartis to focus more on Entresto and to increase its revenue generation from other drugs.
Photo: Taki Steve | Flickr
