FDA Approvals Roundup: Quviviq, Recorlev, Rexulti

RoundupsRoundups | 12 January 2022 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Quviviq nabs go-ahead for insomnia in adults
Idorsia’s Quviviq (daridorexant; tablets) has been approved for treating adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance, pending controlled substance scheduling.
The approval was based on efficacy findings in two studies (Study 1 and Study 2) in which a total of 1,854 patients from the indicated population were randomized to receive Quviviq or placebo for 3 months. Patients could enter a 9-month extension study (Study 3) following the treatment.
At months 1 and 3, Study 1 investigators found a statistically significant improvement in latency to persistent sleep (LPS), wake after sleep onset (WASO), and self-reported total sleep (sTST) for 25- and 50-mg Quviviq compared with placebo. Study 2 findings showed a statistically significant improvement in WASO and sTST for 25 mg Quviviq compared with placebo. Quviviq 10 mg in Study 2 did not show a statistically significant improvement on LPS, WASO, or sTST at either time point. The 10-mg dose is not approved.
The 50-mg dose in Study 1 also demonstrated significant reduction in daytime sleepiness compared with placebo. Results on that measure for the 25-mg dose did not reach statistical significance in either study at either time point.
Final data for Study 3 have been collected for the primary outcome measure and submitted to ClinicalTrials.gov.
Recorlev okayed for adults with Cushing’s-related endogenous hypercortisolemia
Xeris Biopharma’s Recorlev (levoketoconazole; tablets) has been approved for treating endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative.
The approval of Recorlev was based on findings from the SONICS and LOGICS studies in a total of 166 patients from the indicated population. SONICS findings showed Recorlev reduced and normalized mean urinary-free cortisol concentrations without a dose increase. LOGICS findings supplemented SONIC findings compared with placebo. The ongoing, open-label OPTICS study will examine long-term use of the drug.
Recorlev received orphan drug designation for the treatment of endogenous Cushing's syndrome. It comes with a boxed warning for hepatotoxicity and QT prolongation.
New indications
Rexulti use expanded for schizophrenia in adolescents
Otsuka’s Rexulti (brexpiprazole; tablets) has been granted a new indication for treating schizophrenia in patients aged 13 to 17 years.
The application for this indication for Rexulti was granted priority review. The approval comes with a boxed warning for increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors.
Rexulti was originally approved in 2015 for treating schizophrenia and as an adjunctive therapy for major depressive disorder in adults.
Brexpiprazole was discovered by Otsuka Pharmaceutical, Tokyo, and is being co-developed in the US by Otsuka and Lundbeck.


© 2023 Regulatory Affairs Professionals Society.

Tags: FDA, US

Discover more of what matters to you