EU Could Rule Against Novartis Serelaxin

EU Could Rule Against Novartis Serelaxin

After an FDA rejection and an earlier negative opinion, Novartis' cardio treatment serelaxin has again failed to sway European regulators, and the drugmaker has resigned that its breakthrough-designated therapy will not hit any market this year.

Europe's Committee for Medicinal Products for Human Use has reaffirmed its feelings on serelaxin's potential as a treatment for acute heart failure (AHF), echoing its January ruling that it needs to see more clinical evidence before it can approve the drug. In its initial review, CHMP said the drug provided unconvincing short-term relief of heart disease symptoms and cloudy 5-day efficacy in patients with AHF. Reexamining the application, the committee came to the same conclusion, telling Novartis to come back when it has more data.

The FDA made a similar determination last week, saying it needed more evidence of efficacy before it could approve the treatment, which was developed under the moniker RLX030. Now, both regulators are holding out for data from Novartis' ongoing Phase III trial, a 6,300-patient outcomes study with results expected by 2016.

"We are disappointed that patients in Europe will not have access to RLX030 in 2014, but we believe in the value that RLX030 can bring to patients and are committed to extending the current evidence base to confirm this," Global Head of Development Tim Wright said in a statement.

Novartis has said it plans to "expedite" its clinical trial program for serelaxin, expecting to resubmit for EU and U.S. approvals once it has some results from that second Phase III study, dubbed RELAX-AHF-2.

The drug, a synthetic form of the the hormone relaxin, was meant to become a cornerstone of a Novartis' planned cardiovascular franchise, alongside the promising chronic heart failure treatment LCZ696. Serelaxin was among the first drugs added to the FDA's stable of so-called breakthrough therapies, joining a program that has shepherded the likes of Roche ($RHHBY), Johnson & Johnson ($JNJ) and Gilead Sciences ($GILD) to early approvals. Novartis long touted the drug as a blockbuster in the making, expecting sales to peak well above $1 billion a year.