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Veligrotug vs Tepezza: the second TED therapy approaches FDA approval with a shorter infusion schedule and broader indication

Viridian Therapeutics' veligrotug has a PDUFA date of June 30, 2026 for thyroid eye disease. If approved, it would be the second FDA-approved TED therapy after Tepezza (teprotumumab), with five 30-minute infusions versus eight 60–90 minute infusions. This guide covers the THRIVE and THRIVE-2 phase 3 results, access implications for ophthalmology and endocrinology, prior authorization considerations, buy-and-bill economics, and how payers are likely to position the two competing TED therapies.

Ran Chen
Ran Chen
10 min read · Published · Source-cited

On June 30, 2026, the FDA is expected to decide on Viridian Therapeutics' Biologics License Application (BLA) for veligrotug, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody for the treatment of thyroid eye disease (TED). If approved, veligrotug would be only the second FDA-approved therapy for TED — after Amgen's Tepezza (teprotumumab-trbw), which launched in January 2020 and generated $1.85 billion in 2024 revenue.

The BLA was accepted under Priority Review and veligrotug holds Breakthrough Therapy Designation, reflecting the FDA's recognition that a second TED treatment option addresses a significant unmet need. The application is supported by two phase 3 trials — THRIVE (active TED) and THRIVE-2 (chronic TED) — both of which met all primary and secondary endpoints with high statistical significance (p < 0.0001).

For ophthalmology and endocrinology practices, specialty pharmacies, and payer organizations, the potential arrival of veligrotug raises immediate questions about formulary positioning, prior authorization criteria, buy-and-bill economics, and how the two IGF-1R therapies will compete. This guide covers the evidence, the access landscape, and what stakeholders should be preparing.

Short answer

Parameter Veligrotug Tepezza (teprotumumab-trbw)
Generic name Veligrotug Teprotumumab-trbw
Drug class Anti-IGF-1R monoclonal antibody Anti-IGF-1R monoclonal antibody
Sponsor Viridian Therapeutics Amgen (acquired from Horizon Therapeutics)
Application type BLA (new) Approved January 2020
PDUFA date June 30, 2026 N/A
Designations Breakthrough Therapy, Priority Review Orphan Drug
Indication sought Active and chronic TED Active TED only
Dosing Five 30-minute IV infusions, every 3 weeks Eight 60–90-minute IV infusions, every 3 weeks
Treatment duration 12 weeks 21–24 weeks
Pivotal trials THRIVE, THRIVE-2 OPTIC, OPTIC-X
Benefit type Medical benefit (buy-and-bill) Medical benefit (buy-and-bill)
HCPCS code TBD (likely new J-code) J2781

Thyroid eye disease: the clinical landscape

Thyroid eye disease (TED) is an autoimmune condition in which inflammatory cells attack the tissues around the eyes, causing proptosis (eye bulging), diplopia (double vision), pain, redness, and in severe cases, vision loss. TED occurs most commonly in patients with Graves' disease and hyperthyroidism, though it can also appear in hypothyroid and euthyroid patients.

Before Tepezza's approval in 2020, treatment options were limited to corticosteroids, orbital radiation, and surgery — all of which carry significant morbidity and do not directly address the underlying IGF-1R-mediated inflammation. Tepezza transformed TED management by demonstrating meaningful reductions in proptosis and diplopia, but access has been constrained by cost, infusion logistics, and prior authorization requirements.

THRIVE and THRIVE-2: the pivotal evidence

THRIVE — active TED (NCT05176639)

THRIVE was a global, randomized, double-blind, placebo-controlled phase 3 trial in 75 patients with active TED. Key results:

  • Primary endpoint: Proptosis response (≥ 2 mm reduction) at week 15 — met with high statistical significance (p < 0.0001)
  • Secondary endpoints: Met all secondary endpoints including diplopia response, Clinical Activity Score (CAS) improvement, and overall response
  • Rapid onset: Clinical benefit was observed early in the treatment course
  • Safety: Generally well tolerated

THRIVE-2 — chronic TED (NCT06021054)

THRIVE-2 was a global, randomized, double-blind, placebo-controlled phase 3 trial in 125 patients with chronic TED. This is particularly notable because Tepezza is approved only for active TED, leaving chronic TED patients without an FDA-approved targeted therapy.

  • Primary endpoint: Proptosis response at week 15 — met with high statistical significance (p < 0.0001)
  • Secondary endpoints: Met all secondary endpoints including diplopia response and resolution
  • Diplopia resolution: Statistically significant improvement in double vision, a functional endpoint that matters to patients and payers
  • Safety: Generally well tolerated

Clinical advantages over Tepezza

Comparing veligrotug's profile to Tepezza, several differentiating features emerge:

  1. Fewer infusions: Five infusions versus eight, reducing infusion center utilization and patient burden
  2. Shorter infusion time: 30-minute infusions versus 60–90 minutes for Tepezza
  3. Shorter treatment course: 12 weeks total treatment duration versus 21–24 weeks for Tepezza
  4. Broader indication: THRIVE-2 supports a chronic TED indication, which Tepezza does not carry. Many TED patients have chronic disease at presentation
  5. Higher IGF-1R affinity: Veligrotug has a greater binding affinity for IGF-1R, which may translate to efficacy differences, though head-to-head data does not exist
  6. Durability data: Viridian presented long-term durability data in May 2025, which may support the BLA

These advantages could position veligrotug as the preferred IV therapy for TED if payers provide access, though Tepezza's established market presence and Amgen's commercial infrastructure should not be underestimated.

Access implications: what payers and providers should prepare for

Medical benefit and buy-and-bill

Like Tepezza, veligrotug will be administered as an intravenous infusion in a clinical setting, placing it squarely in the medical benefit with buy-and-bill reimbursement. Key considerations:

  • HCPCS coding: Veligrotug will need a new HCPCS code (J-code or temporary Q-code). Amgen's Tepezza uses J2781 (teprotumumab-trbw, 1 mg). CMS typically assigns temporary codes for new products, with permanent J-codes arriving in the annual January update cycle. If approved June 30, veligrotug could receive a temporary Q-code by Q4 2026 or a permanent J-code in January 2027
  • Interim billing risk: Between FDA approval and HCPCS code assignment, providers may need to bill using an unlisted code (J3590 or J9999), which creates reimbursement delays and denials
  • ASP-based reimbursement: Once a code is assigned, reimbursement will follow the Medicare Part B Average Sales Price (ASP) methodology — ASP + 6% for physician-administered drugs
  • Buy-and-bill economics: Providers will purchase veligrotug up front and seek reimbursement through claims. The fewer number of infusions (5 vs 8) could improve provider margin per treatment course if acquisition cost is competitive

Prior authorization considerations

Payers that currently manage Tepezza access through prior authorization will need to develop criteria for veligrotug. Expected PA requirements:

  • Diagnosis confirmation: Documentation of TED diagnosis, including clinical activity score (CAS) and proptosis measurement
  • TED classification: Whether the patient has active or chronic TED (relevant for veligrotug vs Tepezza)
  • Prior treatment: Documentation of prior corticosteroid use or clinical rationale for targeted therapy
  • Ophthalmology or endocrinology specialist: PA likely restricted to prescribing by relevant specialists
  • Imaging: May require orbital imaging (CT or MRI) to confirm TED diagnosis and severity

Formulary positioning: veligrotug vs Tepezza

Payers face a formulary decision that does not yet exist in TED — choosing between two IGF-1R antibodies:

  • Preferred product strategy: PBMs and health plans may designate one product as preferred, requiring step therapy or prior authorization for the other
  • Clinical differentiation: Veligrotug's chronic TED indication (if granted) and shorter treatment course could justify preferred status for patients where those factors are relevant
  • Cost competition: Amgen may respond to veligrotug's entry with pricing concessions or enhanced rebate offers to protect Tepezza's market position
  • Site-of-care considerations: Fewer and shorter infusions may reduce total treatment cost (infusion center overhead, nursing time, monitoring), which payers will evaluate in total cost-of-care calculations
  • Biosimilar threat: Tepezza's composition-of-matter patent expires in the 2032–2034 timeframe. Veligrotug's competitive pressure could accelerate Amgen's lifecycle planning

Specialty pharmacy and REMS considerations

Neither Tepezza nor veligrotug is expected to require REMS, but specialty distribution logistics will still apply:

  • Buy-and-bill purchasing: Providers purchase through specialty distributors (e.g., McKesson, AmerisourceBergen, Cardinal Health)
  • Limited distribution network: Amgen uses a limited distribution network for Tepezza. Viridian may pursue a similar strategy or a broader open-network model
  • Patient support programs: Viridian will need to establish patient assistance, copay support, and benefit investigation services to compete with Amgen's established infrastructure

The pipeline beyond veligrotug: elegrobart (VRDN-003)

Viridian is not stopping with veligrotug. The company is also advancing elegrobart (VRDN-003), a subcutaneous anti-IGF-1R antibody for TED that would eliminate the need for IV infusion entirely. Key milestones:

  • REVEAL-1 (active TED): Positive topline results reported in Q1 2026, meeting the primary endpoint
  • REVEAL-2 (chronic TED): Positive topline results reported in Q1 2026, meeting the primary endpoint
  • Administration: Subcutaneous autoinjector, self-administered by patients
  • Potential advantage: If approved, elegrobart could shift TED treatment from the medical benefit to the pharmacy benefit, fundamentally changing the access and reimbursement landscape

Elegrobart could represent the most significant competitive disruption to both Tepezza and veligrotug, as a self-administered subcutaneous injection would be far more convenient than either IV product. Viridian plans to file a BLA for elegrobart in Q1 2027, with potential approval in late 2027 or early 2028.

However, Amgen is not standing still. The company reported positive phase 3 results for a subcutaneous formulation of Tepezza using a wearable on-body injector, with proptosis response rates near 77% — comparable to the IV formulation. The subcutaneous Tepezza is administered as a two-weekly injection rather than three-weekly IV infusions. If approved, subcutaneous Tepezza would compete directly with elegrobart and potentially limit veligrotug's window of competitive advantage on convenience.

The TED market is therefore heading toward a four-product competitive landscape: IV Tepezza, IV veligrotug, subcutaneous Tepezza, and subcutaneous elegrobart — with timing, convenience, and payer positioning determining market share.

What to watch

  • June 30, 2026: PDUFA target action date for veligrotug BLA
  • Labeling language: Whether the FDA grants a broader label covering both active and chronic TED, or restricts to active TED like Tepezza
  • Pricing announcement: Viridian's WAC for veligrotug will determine the competitive dynamic with Tepezza
  • HCPCS code assignment: Timing of temporary and permanent codes will affect reimbursement speed
  • PBM formulary decisions: CVS Caremark, Express Scripts, and OptumRx will need to decide how to position two IV TED therapies
  • Elegrobart phase 3 results: Both REVEAL-1 and REVEAL-2 reported positive topline data in Q1 2026, supporting a planned BLA submission in Q1 2027
  • Amgen's competitive response: Tepezza pricing, rebate, and contracting strategy in response to new competition

Sources

Topics
PDUFA DateFDA ApprovalOphthalmologySpecialty DrugsPayer CoverageBuy and BillHCPCS CodingMedical BenefitPrior AuthorizationClinical Evidence
Ran Chen
Contributing Editor
Ran Chen

Founder, PharmaDossier. Life-sciences operator covering market access, specialty pharma, biosimilars, and regulated healthcare growth.

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