Jardiance (empagliflozin) for CKD, Welireg (belzutifan) for RCC, Tevimbra (tislelizumab) for Esophageal Squamous Cell Carcinoma, Neffy Epinephrine Nasal Spray

New FDA Approvals

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In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from September 18, 2023 – September 22, 2023. Please check back every Monday morning so that you can stay up to date.

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See more details summaries and links to prescribing information at nascentmc.com/podcast

Here are the highlights:

Jardiance (empagliflozin) for CKD The FDA has approved Jardiance, an SGLT2 inhibitor, for patients with end-stage kidney disease, speciifically to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. The approval is based on the EMPA-KIDNEY phase 3 trial, demonstrating a significant reduction in kidney disease progression and cardiovascular death compared to a placebo.

Welireg (belzutifan) for Advanced Renal Cell Carcinoma The FDA granted Priority Review for Merck's Welireg for advanced renal cell carcinoma post other treatments. Welireg, a HIF-2α inhibitor, is being evaluated in the LITESPARK-005 trial, where it was compared with everolimus for advanced RCC treatment post PD-1/L1 or VEGF-TKI therapies.

Tevimbra (tislelizumab) for Esophageal Squamous Cell Carcinoma The FDA is reviewing an application for Tevimbra for treating advanced or metastatic esophageal squamous cell carcinoma. Supported by the phase 3 RATIONALE 306 study, the drug improves overall survival rates when combined with chemotherapy in these patients.

Neffy Epinephrine Nasal Spray The FDA rejected the approval of Neffy, a needle-free nasal spray for allergic reactions. Despite a positive Advisory Committee vote, the FDA demands further testing. ARS Pharmaceuticals plans to re-submit its application and appeal the decision in 2024.

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