Elevidys package insert

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Actual: Elevidys, a gene therapy costing $3.2 million per patient package insert). The FDA approval history of this product is marked
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by UMP Subcommittee 2024Elevidys in accordance to the package insert for Elevidys (See Appendix A for Vyondys 53 intravenous infusion [prescribing information].

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Elevidys. Package Insert - ELEVIDYS (fda.gov). Revised 10/2024. Member Product. Medical Management Requirements. New York Products. HMO. Prior

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ELEVIDYS is the recombinant gene therapy product that is comprised of a Elevidys (Delandistrogene moxeparvovec) [package insert]. Silver Spring, MD

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AMONDYS 45 [Product Information]. Cambridge, Mass. Sarepta Accessed on Ma. 10. Elevidys [package insert]. Cambridge

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ELEVIDYS (Sarepta Therapeutics, Inc.): FDA Package Insert. Sarepta Therapeutics, Inc. ELEVIDYS- delandistrogene moxeparvovec-rokl. Sarepta Therapeutics, Inc. 1 INDICATIONS AND USAGE. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age:

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by UMP Subcommittee 2024Elevidys in accordance to the package insert for Elevidys (See Appendix A for recommended pre- and post-infusion corticosteroid dosing); AND.

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Vyondys 53 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in Package Insert - ELEVIDYS (fda.gov). Revised 10/2024. Member

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Elevidys is the first gene therapy approved for ambulatory tion: Package Insert - ELEVIDYS (fda.gov); 19FDA Approves First Gene

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Elevidys and priced it to match the hype at $3.2 million. - The Lenmeldy aims to insert functional genes into patients' cells to

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