The FDA (U.S. Food and Drug Administration) announced its formal rejection Novartis’ experimental AHF (acute heart failure) treatment serelaxin (RLX030). The agency cited reasons much like the reasons that were behind the drug’s three prior regulatory fails earlier this year. The FDA told Novartis that additional proof concerning the efficiency of RLX030 is needed before approval will be given.
The FDA’s CRDAC (Cardiovascular and Renal Drugs Advisory Committee) voted on March 27 to recommend the FDA turn down approval of serelaxin (RLX030) trade-named Reasanz. The CRDAC report raised three significant concerns:
They noted that Novartis relied heavily on only one clinical trial to ascertain the drug’s “effect on dyspnea” instead of two or more or at the very least a single test “with data for multiple studies.” The one test in question gave the lowest scores to participants who passed away or suffered from “worsening heart failure” over the initial 5 days. (In fact, the FDA actually inquired as to what the initial trial’s results would have been if a different score had been given.)
The report also pointed out that the trial centered upon RLX030’s “beneficial effect on dyspnea” which was disregarded by the FDA “as an exploratory finding” that simply didn’t devote itself to the “AHF indication.”
Novartis released a statement saying that they will continue to seek approval and further evidence of serelaxin’s efficacy. Tim Wright, global head of development for Novartis Pharmaceuticals, stated: “In accordance with the FDA’s advice we will continue to expedite our clinical trial program to build the supporting body of evidence.”
Thus far the company has submitted both phase II and III efficacy and safety data from a study involving 1,161 patients. The results from the RELAX-AHF research demonstrate that participants who were treated with RLX030 “had a 37% reduction in mortality at six months after an AHF episode” in comparison to patients who only received the “conventional treatment.”
The company will be studying 6,300 more heart patients in another series of tests. The results will be released in 2016. Wright concluded: “We continue to believe RLX030 has the potential to be an important treatment for AHF and have been encouraged by feedback from FDA advisory committee members . . .”