Novartis AG FDA publishes staff notes
**Note on March 27th, the FDA Cardiovascular and Renal Drugs Advisory Committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.
Novartis’s serelaxin shouldn’t be approved for proposed use to reduce symptoms of acute heart failure, FDA clinical reviewer said in report.
- FDA clinical reviewer cites “insufficient evidence” to support use, says no signficant safety concerns were identified that preclude approval
- NVS expects data in 2016 from separate Phase 3 study of serelaxin to reduce death risk
- Co. decided to seek approval based on data from single study, even though two pivotal studies are usually required for approval: Rob Kowalski, NVS’s global head of drug regulatory affairs, in Feb. interview
- FDA advisory panel will review findings at March 27 meeting
- Review initially scheduled for Feb. 13 was postponed because of weather
- Bloomberg Industries est. Pdufa date is in May; serelaxin received breakthrough status from FDA in June 2013
- Analysts est. 2018 serelaxin sales $523.1m: Bloomberg data; Endo has Canadian rights to drug
- Other cos. developing drugs for acute heart failure include Forest Labs/Trevana, Amgen/Cytokinetics/Servier: BI
- NOTE: NVS appealing EU panel’s recommendation against serelaxin in Jan., seeking conditional approval to sell drug contingent on larger mortality study showing benefit
