Talzenna, Elevidys, Jardiance, Litfulo, Blincyto, Vyvgart Hytrulo, Ultravist

New FDA Approvals

Get our free download! Implementing AMA Style – 8 Things to Get Right

In this episode, we discuss the latest FDA approvals from June 19 – June 23, 2023. Here are the key highlights:

· The FDA has given approval to Pfizer's Talzenna and Xtandi for treating metastatic castration-resistant prostate cancer in adults with certain genetic mutations. The approval came following successful Phase 3 TALAPRO-2 trial results.

· Sarepta Therapeutics' Elevidys, a gene therapy for Duchenne muscular dystrophy, has received accelerated approval from the FDA. Elevidys, the first gene therapy of its kind, is approved for ambulatory pediatric patients aged 4-5 years with confirmed mutation in the DMD gene.

· Jardiance and Synjardy, initially approved for adults in 2014 and 2015 respectively, have now been approved by the FDA for use in children aged 10 and older with type 2 diabetes. This approval came on the back of the DINAMO phase 3 trial results.

· Pfizer’s Litfulo, a once-daily oral treatment for severe alopecia areata for individuals aged 12 and older, has received FDA approval. This is the first treatment approved for adolescents with this condition.

· Amgen's Blincyto has received FDA approval for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease. This moves the drug from an accelerated approval to a full approval status.

· Argenx's Vyvgart Hytrulo, a subcutaneous version of the original drug Vyvgart, has been approved by the FDA. It is indicated for generalized myasthenia gravis (gMG) in adult patients who test positive for anti-acetylcholine receptor antibodies.

· Bayer's Ultravist (iopromide) injection, the first contrast agent for contrast-enhanced mammography, has been approved by the FDA. This new imaging tool enhances visibility of suspected or known breast lesions.

· The FDA has refused to grant accelerated approval to Intercept Pharmaceuticals' drug obeticholic acid (OCA) for treating non-alcoholic steatohepatitis (NASH). This is the second time the FDA has declined to approve the drug for NASH due to potential risks.

· Please check back every Monday morning for last week's approvals so that you can stay up to date. See all the episodes here.

· This podcast is brought to you by Nascent Medical. If you're a project manager at a CME or medical communications agency and need on-call medical writing assistance please visit Nascent Medical. We are a team of MD- and PhD-level medical writers and can create slide decks, white papers, ad board summaries, manuscripts, needs assessments, and much more. We also do medical editing using AMA style and factchecking. Visit nascentmc.com

· Intro and outro music

· Garden Of Love by Pk jazz Collective