FDA Grants Breakthrough Device Designation to Blue Note...

FDA Grants Breakthrough Device Designation to Blue Note Pharmaceuticals' BNT200

Healthcare Tech Outlook | Tuesday, January 25, 2022

Blue Note Pharmaceuticals' BNT200 platform, which treats anxiety and depression symptoms in AML patients, has been granted Breakthrough Device Designation by the FDA.

Fremont, CA: Patients with AML who are capable of limited self-care or who are eligible for low-intensity induction therapy can benefit from digital platforms with symptom tracking tools. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Blue Note Pharmaceuticals' BNT200. BNT200 is a first-of-its-kind, prescription-only digital medication for the treatment of anxiety and depression symptoms in people with acute myeloid leukemia (AML) who are hospitalized for a high-intensity induction chemotherapy regimen.

"For the thousands of patients diagnosed with AML each year, managing and coping with disease symptoms can be especially difficult," states Areej El-Jawahri, M.D., Massachusetts General Hospital. "The advancement of innovative therapeutic options for the treatment of the associated distress that often follows a diagnosis is promising for patients and addresses an unmet need."

Dr. El-Jawahri is the lead investigator, and his research team is undertaking a clinical trial to see how BNT200 affects patients with AML's quality of life, mood, and symptoms.

"Patients hospitalized after diagnosis with AML often experience a sudden disruption of their life with substantial physical and psychological impacts," comments Geoffrey Eich, CEO of Blue Note Therapeutics. "We are pleased that the FDA has recognized the need to speed up development and review of BNT200, as well as encouraged by our ability to help reduce the symptoms of distress and improve quality of life and care in patients newly diagnosed with AML."

Novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions are given FDA Breakthrough Designation. Positive usability and preliminary efficacy studies backed up Blue Note's application for Breakthrough Device Designation.

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