FDA grants breakthrough device designation to BNT200 for anxiety in acute myeloid leukemia
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The FDA granted breakthrough device designation to BNT200.
BNT200 (Blue Note Therapeutics) is a digital therapeutic designed to treat anxiety and depressive symptoms among adults with acute myeloid leukemia who are hospitalized for high-intensity induction chemotherapy.
BNT200 is intended to be used in the inpatient setting during this 4- to 6-week period. Its content is synchronized with the induction chemotherapy regimen to suppress the psychological stressors these patients endure.
"Patients hospitalized after diagnosis with AML often experience a sudden disruption of their life with substantial physical and psychological impacts," Geoffrey Eich, CEO of Blue Note Therapeutics, said in a company-issued press release. “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 [of] patients newly diagnosed with AML.”
A study is underway to evaluate the effect of BNT200 on quality of life, mood and symptoms among people with AML.
“For the thousands of patients diagnosed with AML each year, managing and coping with disease symptoms can be especially difficult,” principal investigator Areej El-Jawahri, MD, oncologist at Massachusetts General Hospital, said in the release. “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.”
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