Novartis heart failure drug fails to win FDA approval

May 19, 2014

FDA has decided not to approve acute heart failure drug serelaxin (Novartis).

FDA has decided not to approve acute heart failure drug serelaxin (Novartis).

Novartis reportedly has a long-standing commitment to cardiovascular drugs.

FDA asked for more information about serelaxin, according to a statement from the company. A panel of advisers to FDA unanimously recommended against approval March 27. They agreed with FDA staff members who said in a March 25 report that they found insufficient evidence that serelaxin will benefit patients. Novartis said it will expedite a program of clinical trials to gather more evidence.

“The recent FDA decision to hold off on the decision to approve serelaxin based on lack of sufficient data will only enable formulary managers to also assess the benefits and risks of this drug if the decision is ultimately made to approve this agent,” said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

While the drug is considered to have the potential to treat acute heart failure, the delivery of more robust data through the performance of a large clinical trial will only serve to prove whether or not serelaxin is a drug worth further pursuit in the future, according to Dr Farinde.

“Until additional clinical trials can prove the clinical merit, safety, and effectiveness of serelaxin it may be a drug that initially demonstrates great promise but can fall short of producing its intended clinical benefits,” she said.

Serelaxin is a recombinant form of the human hormone relaxin-2 which occurs naturally in both men and women. 

FDA granted serelaxin breakthrough therapy designation in June 2013.