pharmaphorum March 20, 2024
Swedish pharma company Vicore has won breakthrough status from the FDA for Almee, a cognitive behavioural therapy (CBT) app used to support people with pulmonary fibrosis (PF).
Almee takes the form of a nine-week CBT course that has been shown in clinical testing to reduce the psychological burden of living with PF, a progressive and life-threatening disease with an average life expectancy for patients of just three to five years. It is being developed in association with digital health specialist Alex Therapeutics.
The FDA’s breakthrough device designation can speed up the development of new medical devices and digital health technologies, becoming eligible for a prioritised review, which can sometimes result in shorter development and review times.
In the pivotal COMPANION...
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