55 Novel Drug Approvals for 2023

55 new drugs approved by the FDA’s Center for Drug Evaluation (CDER), up from 37 drug approvals in 2022.
32 of these NMEs can be classified as small molecules. Multiple drug modalities – SMs, mAbs, bispecifics, enzyme replacement therapies, ASOs, PET agents, siRNA and bark extracts even.

16 oncology, 6 neuro, 6 I&I, 5 infectious disease, 5 metabolic disorder drugs.

Highlights:

💉Leqembi, an amyloid beta-targeting antibody to treat Alzheimer’s Disease

💊Skyclarys, a new medication used for the treatment of Friedreich’s ataxia

💊Daybue, a novel synthetic analog of glypromate for the treatment of Rett syndrome

💉Rezzayo, an echinocandin antifungal for the treatment of candidemia and invasive candidiasis

💉Elfabrio, a recombinant human α-galactosidase-A for the treatment of Fabry disease

💊Veozah, a selective neurokinin-3 (NK3) receptor antagonist for the
treatment of hot flashes due to menopause

💉Beyfortus, a human recombinant mAb with activity against RSV

💊 Zurzuvae, a medication used for the treatment of postpartum depression

💊 Sohonos, a retinoic acid receptor gamma (RARγ) agonist for the
treatment of heterotopic ossification and FOP

💉Veopoz, a recombinant mAb for the treatment of CD55-deficient protein-losing enteropathy, also known as CHAPLE disease

4Q23 approvals –

💊Velsipity, an S1P receptor modulator used to treat ulcerative colitis

💊Zilucoplan, a complement inhibitor used to treat generalized myasthenia gravis

💉Bimzelx, an anti-IL-17A,-17F, and -17AF mAb used in the treatment plaque psoriasis

💊Agamree, a synthetic glucocorticoid used as an anti-inflammatory and immunosuppressant in the management of Duchenne muscular dystrophy (DMD)

💉Omvoh, an anti-IL-23 mAb used as a second-line therapy for ulcerative colitis

💉Loqtorzi, a PD-1-blocking mAb to treat nasopharyngeal carcinoma (NPC)

💊Fruzaqla, a VEGFR1/2/3 kinase inhibitor for the treatment of colorectal cancer

💉DefenCath, a formulation of taurolidine and heparin to reduce catheter-related bloodstream infections

💊Augtyro, a ROS1 and TRK A/B/C kinase inhibitor for the treatment of breast cancer

💉Ryzneuta, a leukocyte growth factor used to decrease the incidence of infection in chemotherapy-induced neutropenia

💊Truqap, an AKT1/2/3 inhibitor for the treatment of breast cancer

💊 Ogsiveo, a gamma-secretase inhibitor for the treatment of desmoid tumors

💊 Fabhalta, a factor B inhibitor used to treat paroxysmal nocturnal hemoglobinuria

🧴Filsuvez, a herbal medicinal product used to treat partial thickness wounds

💉Wainua, an ASO used for the treatment of transthyretin-mediated amyloidosis

Source: Chris De Savi, LinkedIn