CDER approved 37 novel drugs in 2022, its lowest number since 2016

Regulatory NewsRegulatory News | 05 January 2023 |  By 

After several years with high numbers of novel drug approvals, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 37 new drug therapies in 2022.
 
CDER’s 37 new drug approvals in 2022 represents the lowest number of novel drugs approved by the Center since 2016. The Center approved 50 novel drugs in 2021, 53 novel drugs in 2020, 48 drugs in 2019 and 59 drugs in 2018. (RELATED: FDA approved more first-in-class drugs, gave more accelerated approvals in 2021, Regulatory Focus 7 January 2022)
 
Of the novel products approved by CDER in 2022, the most common therapeutic area was cancer. There were 12 approvals for products indicated for various forms of cancer, including Kimmtrak and Opdualag for unresectable or metastatic melanoma, Vonjo for intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets, Pluvicto for metastatic castration-resistant prostate cancer, Rolvedon for reducing infection in non-myeloid malignancies, Lytgobi for intrahepatic cholangiocarcinoma, Imjudo for unresectable hepatocellular carcinoma, Tecvayli for relapsed or refractory multiple myeloma, Elahere for recurrent ovarian cancer, Rezlidhia for relapsed or refractory acute myeloid leukemia, Krazati for KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, and Lunsumio for relapsed or refractory follicular lymphoma.
 
FDA’s CDER also approved five novel products in dermatology, which included Cibinqo as a treatment for refractory moderate-to-severe atopic dermatitis, Vtama for plaque psoriasis and the TYK2 inhibitor Sotyktu for moderate-to-severe plaque psoriasis, Spevigo for generalized pustular psoriasis flares, and Daxxify for moderate-to-severe glabellar lines.
 
Other notable novel approvals include diabetes drugs indicated to delay stage 3 type 1 diabetes (Tzield) and control blood sugar levels (Mounjaro), approvals for products to treat genetic disorders acid sphingomyelinase deficiency (Xenpozyme) and seizures in CDKL5 deficiency disorder (Ztalmy), and ophthalmology products to treat intraocular pressure in open‑angle glaucoma or ocular hypertension (Omlonti) and aged-related macular degeneration and diabetic macular edema (Vabysmo).
 
CDER additionally approved novel drugs with uses in insomnia (Quviviq), cold agglutinin disease (Enjaymo), recurrent vulvovaginal candidiasis (Vivjoa), Helicobacter pylori infection (Voquezna), polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (Amvuttra), hepatorenal syndrome (Terlivaz), identifying lesions in the central nervous system (Elucirem), amyotrophic lateral sclerosis (Relyvrio), multiple sclerosis (Briumvi), pulmonary function (Xenoview), HIV (Sunlenca) and partial/full thickness burns (NexoBrid).
 
 
CBER’s approvals in 2022
 
FDA’s Center for Biologics Evaluation and Research (CBER) approved Biologics License Applications (BLAs) for 8 new products in 2022, down from 10 new products the Center approved in 2021. CBER approved BLAs for 8 new products in 2020, 20 new products in 2019 and 5 new products in 2018.
 
Many of CBER’s approvals in 2022 were gene therapies to treat or cure rare diseases. In total, four gene therapy products had BLAs approved, including Zynteglo for ß-thalassemia in adult and pediatric patients who need regular red blood cell transfusions, Skysona to slow neurologic dysfunction progression in active cerebral adrenoleukodystrophy for pediatric and adolescent patients, Hemgenix for patients with hemophilia B already receiving factor IX prophylaxis or patients with serious bleeding or hemorrhaging problems and Adstiladrin for high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer. In the oncology space, CBER approved Carvykti, an immunotherapy treatment for relapsed or refractory multiple myeloma.
 
CBER also approved Rebyota in 2022, a microbiota restoration therapy indicated to prevent Clostridioides difficile infection recurrence in adults. Additionally, two vaccines were approved in 2022 by CBER: the live measles, mumps, and rubella vaccine Priorix, which is indicated for children and adults, as well as the COVID-19 vaccine Spikevax for individuals 18 years and older.
 
 
CDER: Novel Drug Approvals for 2022
 
CBER: 2022 Biological License Application Approvals

 

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