USPSTF recommendations on estrogen and progesterone; semaglutide assessed in obese teenagers; efficacy and safety data released for investigational maternal RSV vaccine; updates to Clozapine REMS; FDA panel votes on investigational CNS/leptomeningeal metastasis treatment.
The FDA does not intend to object if inpatient pharmacies dispense a days’ supply of clozapine that aligns with the patient’s monitoring frequency upon discharge from the facility.
The table provided is a review of notable updates that occurred in September 2022 for investigational products in development.
The NDA is supported by data from a phase 1/2 trial that compared the investigational aripiprazole 2-month, long-acting injectable to aripiprazole 1-month depot.
The phase 3 EMERGENT-2 trial included 252 patients with schizophrenia who were experiencing symptoms of psychosis.
The patient had been diagnosed with schizophrenia, and suffered from auditory and visual hallucinations, delusions, and extreme paranoia.
Caplyta is indicated for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorders, as monotherapy and as adjunctive therapy with lithium or valproate.
The CRL states that the application cannot be approved in its current form.
The approval was based on data from the phase 3 SERENITY I and II studies that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively.
