| Muscular Dystrophy, Duchenne
Vyondys 53 vs Emflaza
Side-by-side clinical, coverage, and cost comparison for muscular dystrophy, duchenne.Deep comparison between: Vyondys 53 vs Emflaza 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 signalsEmflaza has a higher rate of injection site reactions vs Vyondys 53 based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Emflaza but not Vyondys 53, including UnitedHealthcare
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Category
Vyondys 53
Emflaza
At A Glance
IV infusion
Once weekly
Exon 53 skipping antisense oligonucleotide
Oral
Once daily
Corticosteroid
Indications
- Muscular Dystrophy, Duchenne
- Muscular Dystrophy, Duchenne
Dosing
Muscular Dystrophy, Duchenne 30 mg/kg IV infusion once weekly over 35 to 60 minutes via an in-line 0.2 micron filter.
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.
Contraindications
- Serious hypersensitivity reaction to golodirsen or any inactive ingredient in VYONDYS 53
- Known hypersensitivity to deflazacort or any of the inactive ingredients
Adverse Reactions
Most common (>=20%) Headache, pyrexia, fall, abdominal pain, nasopharyngitis, cough, vomiting, nausea
Serious Hypersensitivity reactions
Postmarketing Anaphylaxis
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
Pharmacology
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.
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.
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Most Common Insurance
Anthem BCBS
Vyondys 53
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (10/12) · Qty limit (0/12)
Emflaza
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (9/12) · Qty limit (0/12)
UnitedHealthcare
Vyondys 53
- Covered on 4 commercial plans
- PA (0/8) · Step Therapy (0/8) · Qty limit (0/8)
Emflaza
- Covered on 4 commercial plans
- PA (3/8) · Step Therapy (1/8) · Qty limit (0/8)
Humana
Vyondys 53
- Covered on 0 commercial plans
- PA (1/3) · Step Therapy (1/3) · Qty limit (0/3)
Emflaza
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (2/3) · Qty limit (1/3)
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.