Talzenna, Elevidys, Jardiance, Litfulo, Blincyto, Vyvgart Hytrulo, Ultravist
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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.
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· Intro and outro music
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