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Novartis Releases a New Drug Amid Disapproval by FDA

Novartis

Pharmaceutical giant Novartis released a drug that was voted against by the US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee or CRDAC. The drug has been called RLX030 or Serelaxin. It is a medication discovered by Novartis to treat acute heart failure [AHF].

Novartis Releases a New Drug Amid Disapproval by FDA

The research material presented to the approval committee contained within it safety and efficiency data from Phase II and Phase III of the clinical trials of RLX030. This also incorporated the clinical crucial phase III RELAX-AHF study. The FDA deemed the data and its evidence insufficient and has strictly recommended against it being made available to the public. However, there were no safety concerns issued by the reviewers.

“I think this was more of a failure of trial design than it was of the drug itself”, said Dr. Stuart Rich, Managing Director of the University Of Chicago Pritzker School Of Medicine. He was one the members on the panel. Dr. Philip Sagar, Managing Director of Stanford University School of Medicine, said something to the same effect, “I do want to applaud the sponsor for working to develop this drug for acute HF. This is a difficult area to develop drugs in and is an unmet medical need. I think that the data we looked at today show that there’s real potential for helping patients with harder endpoints, in reduced worsening of congestive heart failure, reduced time in the hospital and reduced time in the ICU and potentially improving cardiac as well as renal biomarkers. I hope that this disappointing vote and meeting today won’t preclude the sponsor from continuing to develop the drug.”

Novartis claims that the drug improves the symptoms of acute heart failure and can prevent the condition from worsening. The pharmaceutical giant has agreed to work with the FDA in reviewing its data and showcase it in a different light in a hearing scheduled in May.

 

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