Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder.
Rejoyn (formerly CT-152), a software-as-a-medical device (SaMD) delivered via a smartphone app, has been authorised as an add-on to clinician-managed outpatient care for adults aged 22 and over with MDD who require antidepressant medicines.