2023 New Drug Approvals: Part 1

Take a look back at the novel drugs and therapeutics approved by the FDA in 2023,¹ including treatments for Alzheimer disease, type 2 diabetes, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, and more.

References

1. Novel drug approvals for 2023. FDA. Reviewed November 28, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023

2. FDA grants accelerated approval for Alzheimer’s disease treatment. News release. FDA. January 6, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment

3. TheracosBio announces FDA approval of Brenzavy (bexagliflozin) for the treatment of adults with type 2 diabetes. News release. TheracosBio. January 23, 2023. Accessed November 28, 2023. https://www.businesswire.com/news/home/20230123005126/en/TheracosBio-Announces-FDA-Approval-of-Brenzavvy%E2%84%A2-bexagliflozin-for-the-Treatment-of-Adults-with-Type-2-Diabetes

4. US FDA approves Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least two lines fo systemic therapy, including a BTK inhibitor. News release. Eli Lilly. January 27, 2023. Accessed November 28, 2023. https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jaypircatm-pirtobrutinib-first-and-only-non

5. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. FDA. January 27, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer

6. FDA approves first oral treatment for anemia caused by chronic kidney disease for adults on dialysis. News release. FDA. February 1, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis

7. FDA approves first enzyme replacement therapy for rare alpha-mannosidosis. FDA. February 17, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-enzyme-replacement-therapy-rare-alpha-mannosidosis

8. Travere Therapeutics announces FDA accelerated approval of Filsparitm (sparsentan), the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy. News release. Travere Therapeutics. February 17, 2023. Accessed November 28, 2023. https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-announces-fda-accelerated-approval

9. FDA approves first treatment for Friedreich’s ataxia. FDA. February 28, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia