together with Dr. Naveed Yasin, Dr. Jen Huen, and Dr. Adrian Parodi
There were four novel drugs approved by the FDA in January 2022 (2 small molecules, 2 large molecules). The novel January 2022 new drug approvals appear below in this Drug Hunter minireview:
Novel small molecule FDA drug approvals of January 2022:
- Quviviq (daridorexant): Oral dual orexin receptor blocker (OX1/OX2); for insomnia in adults; antagonizes orexin neuropeptide mediated wakefulness.
- CibinqoTM (abrocitinib): Oral JAK1-selective inhibitor (9-28x); 100 or 200 mg QD; for refractory atopic dermatitis in adults; reduces inflammatory cytokines.
Novel large molecule FDA drug approvals of January 2022:
- Kimmtrak® (tebentafusp): Injectable bispecific gp100 peptide-HLA-directed CD3 T cell engager; for treating patients with HLA-A*02:01 positive patients with unresectable or metastatic uveal melanoma; induces lysis of uveal cancer cells by stimulating T cells to release inflammatory cytokines and cytolytic proteins.
- VabysmoTM (faricimab): Injectable VEGF and Ang-2 inhibitor; for treating nAMD and DME; inhibits neovascularization and promotes vascular stability.
More detailed summaries about each Jan. 2022 FDA new drug approval appear below.
Quviviq (daridorexant), a November 2020 Molecule of the Month, is an oral dual-orexin receptor antagonist (DORA) approved for the treatment of insomnia in adult patients with difficulty in falling asleep or staying asleep. For such patients (DSM-5 insomnia), the drug significantly reduced wakefulness after sleep onset (WASO, difference of up to 18 minutes), latency to persistent sleep (LPS, difference of up to 12 minutes), and improved subjective total sleep time (sTST, difference of 20 minutes) when compared to placebo.
The drug is an orexin inhibitor and exerts its effect by binding to and blocking orexin receptors. Orexins (orexin 1 and orexin 2) are endogenous neuropeptides that play a significant role in wakefulness. These neuropeptides increase awake time and reduce sleeping time (including decreased REM and non-REM sleep). Blocking the orexin receptors antagonizes the effects of these peptides, leading to improvement in sleep onset and maintenance.
Two other DORA drugs have been approved for the same indication: Belsomra® (suvorexant) and DayvigoTM (lemborexant). Compared to Belsomra (half-life 12 hours) and Dayvigo (half-life 17 hours), Quviviq has a shorter half-life (8 hours) that could reduce morning grogginess among patients.
DORA drugs are the result of over two decades of research into the orexin pathway, and as a class offer a distinct mode of action to benzodiazepines. As many patients’ insomnia is triggered by anxiety, depression, chronic pain, and other stimuli, DORAs won’t replace benzodiazepines, but are a helpful new tool in treating subtypes of insomnia.
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