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Novartis Receives 16th FDA Breakthrough Therapy Designation

June 22, 2013

Please bookmark the following Orphan Druganaut Blog Post’s URL, which will always contain the latest FDA Breakthrough Therapy Designation Chart.

Novartis announces on June 21, 2013, that the FDA has given the Breakthrough Therapy Designation to the company’s non-orphan drug Serelaxin (RLX030), an investigational treatment for patients with Acute Heart Failure (AHF). The FDA concludes that Serelaxin qualifies for the Breakthrough Therapy Designation because the drug is a substantial improvement over currently available therapies for AHF, a life-threatening illness. The FDA’s decision is supported by efficacy and safety results from a Phase III (RELAX-AHF) study. Also, this study shows that patients receiving Serelaxin had a 37% reduction in mortality at 6 months after an AHF episode, compared to patients who receive conventional treatment.

Serelaxin, if approved, has the potential to be the first treatment breakthrough for AHF patients in 20 years. This is the second FDA Breakthrough Therapy designation for Novartis, following LDK378 for Non-Small Cell Lung Cancer (NSCLC).

Approximately 3.5 million AHF episodes occur each year in the US and the EU. As the population ages, this number is expected to increase. Each AHF episode “contributes to a downward spiral of worsening heart failure and damage to vital organs, such as the heart and kidneys, which decreases the chance of the patient surviving another episode.”

Serelaxin is currently being assessed by health authorities around the world including the FDA and the European Medicines Agency (EMA) for the treatment of AHF.

Please Note #1: The Orphan Druganaut Blog has decided to include a Post on Serelaxin even though it isn’t an orphan drug, because the Blog has been following the new FDA Breakthrough Therapy designations since the beginning of 2013.

Please Note #2: FDA Official Logo from FDA website.

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