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Amondys 45 FDA Approval History

Last updated by Judith Stewart, BPharm on April 6, 2021.

FDA Approved: Yes (First approved February 25, 2021)
Brand name: Amondys 45
Generic name: casimersen
Dosage form: Injection
Company: Sarepta Therapeutics
Treatment for: Duchenne Muscular Dystrophy

Amondys 45 (casimersen) is an antisense oligonucleotide for the treatment of patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene.

  • Amondys 45 is approved under accelerated review based on an increase in dystrophin production in skeletal muscle of patients amenable to exon 45 skipping. Continued approval may be contingent upon verification of a clinical benefit in confirmatory trials.
  • Amondys 45 is administered as an intravenous (IV) infusion over 35 to 60 minutes once weekly.
  • Nephrotoxicity has occurred with other antisense oligonucleotides, so renal function should be monitored in patients taking Amondys 45. Creatinine may not be a reliable measure of renal function in DMD patients. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting Amondys 45.
  • Common adverse reactions include upper respiratory tract infection, cough, pyrexia, headache, arthralgia, and oropharyngeal pain.

Development timeline for Amondys 45

Feb 25, 2021Approval FDA Approves Amondys 45 (casimersen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 45
Aug 25, 2020Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45
Jun 26, 2020Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Casimersen (SRP-4045) for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45

Further information

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