Novartis (NVS - Free Report) suffered a setback when the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its Biologics License Application (BLA) for pipeline candidate RLX030 (serelaxin).
Novartis was seeking approval of RLX030 for the treatment of acute heart failure (AHF). The FDA requires further evidence on the efficacy of RLX030 to approve the candidate in the U.S.
The BLA submitted to the FDA included phase II and III efficacy and safety data from the clinical development program on RLX030, including the data from the phase III RELAX-AHF study.
Novartis will now work to expedite its clinical trial program and provide additional data to the FDA. A second phase III study, RELAX-AHF (n=6300) on RLX030 is currently underway to support the efficacy of the candidate.
We remind investors that the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the FDA voted against the approval of the candidate RLX030 in Mar 2014. The FDA had earlier granted Breakthrough Therapy (BT) designation status to RLX030 in Jun 2013.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also issued a negative opinion on RLX030 in Jan 2014.
We are disappointed by the setback of RLX030. We expect investor focus to remain on further updates on revised filing in the U.S. and EU.
Nevertheless, Novartis has another candidate, LCZ696, in its pipeline which is being evaluated for chronic heart failure.
Novartis currently carries a Zacks Rank #3 (Hold). Currently, stocks like Allergan (AGN - Free Report) , Gilead Sciences (GILD - Free Report) and Astellas Pharma, Inc. look attractive in the healthcare sector. While Allergan and Gilead Sciences carry a Zacks Rank #1 (Strong Buy), Astellas Pharma is a Rank #2 (Buy) stock.