Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA

Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.” In addition to getting a speedier review process, the sponsor of a drug with the designation receives “more intensive FDA guidance” on the development program.

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Comments

  1. ” Breakthrough” in medicine is this something like “too big to fail” on Wall Street. After nesiritide, milrinone, ibutilide, multaq to name a few do we really need this obfuscation. Is the future tense of break-through, fell-through.

    Wilbur Larch MD FACC

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