| Muscular Dystrophy, Duchenne
Emflaza vs Vyondys 53
Side-by-side clinical, coverage, and cost comparison for muscular dystrophy, duchenne.Deep comparison between: Emflaza vs Vyondys 53 with Prescriber.AI
AI compares prescribing info and payer-specific access barriers across 1,200+ formularies. Here's a preview of what prescribers are already asking.Safety signalsVyondys 53 has a higher rate of injection site reactions vs Emflaza based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Vyondys 53 but not Emflaza, including UnitedHealthcare
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Category
Emflaza
Vyondys 53
At A Glance
Oral
Once daily
Corticosteroid
IV infusion
Once weekly
Exon 53 skipping antisense oligonucleotide
Indications
- Muscular Dystrophy, Duchenne
- Muscular Dystrophy, Duchenne
Dosing
Muscular Dystrophy, Duchenne 0.9 mg/kg/day once daily orally (tablets or suspension); reduce to one third of recommended dosage when used with moderate or strong CYP3A4 inhibitors; avoid use with moderate or strong CYP3A4 inducers.
Muscular Dystrophy, Duchenne 30 mg/kg IV infusion once weekly over 35 to 60 minutes via an in-line 0.2 micron filter.
Contraindications
- Known hypersensitivity to deflazacort or any of the inactive ingredients
- Serious hypersensitivity reaction to golodirsen or any inactive ingredient in VYONDYS 53
Adverse Reactions
Most common (>=5%) Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, nasopharyngitis, hirsutism, central obesity, erythema, irritability, rhinorrhea, abdominal discomfort
Serious Alterations in endocrine function, immunosuppression and increased infection risk, cardiovascular/renal alterations, gastrointestinal perforation, behavioral and mood disturbances, bone effects, ophthalmic effects, serious skin rashes, growth and development effects, myopathy, Kaposi's sarcoma, thromboembolic events, anaphylaxis
Postmarketing Leukocytosis, heart failure, chorioretinopathy, corneal or scleral thinning, acute pancreatitis, peptic ulceration, edema, hypersensitivity including anaphylaxis, avascular necrosis, vertebral and long bone fractures, toxic epidermal necrolysis, thromboembolism, suicidal thoughts
Most common (>=20%) Headache, pyrexia, fall, abdominal pain, nasopharyngitis, cough, vomiting, nausea
Serious Hypersensitivity reactions
Postmarketing Anaphylaxis
Pharmacology
Deflazacort is a corticosteroid prodrug whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects; the precise mechanism of therapeutic benefit in Duchenne muscular dystrophy is unknown.
Golodirsen is an antisense oligonucleotide of the phosphorodiamidate morpholino oligomer (PMO) subclass that binds to exon 53 of dystrophin pre-mRNA, inducing exon 53 exclusion during mRNA processing to allow production of an internally truncated dystrophin protein in patients with DMD gene mutations amenable to exon 53 skipping.
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Most Common Insurance
Anthem BCBS
Emflaza
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (9/12) · Qty limit (0/12)
Vyondys 53
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (10/12) · Qty limit (0/12)
UnitedHealthcare
Emflaza
- Covered on 4 commercial plans
- PA (3/8) · Step Therapy (1/8) · Qty limit (0/8)
Vyondys 53
- Covered on 4 commercial plans
- PA (0/8) · Step Therapy (0/8) · Qty limit (0/8)
Humana
Emflaza
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (2/3) · Qty limit (1/3)
Vyondys 53
- Covered on 0 commercial plans
- PA (1/3) · Step Therapy (1/3) · Qty limit (0/3)
Coverage data sourced from MMIT. Updated monthly.
Savings
Cost estimate not availableAssistance Fund: Duchenne Muscular Dystrophy
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
Cost estimate not availableAssistance Fund: Duchenne Muscular Dystrophy
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.