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

New FDA Approvals

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.

Check out our free downloads at nascentmc.com:

• Implementing AMA Style – 8 Things to Get Right in Your Next Project
• Needs Assessments – 7 Essentials for Getting Funded
• Working With Your Medical Writer – 8 Ways to Get the Most out of Them

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.

Intro and outro music

Garden Of Love by Pk jazz Collective