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Avlayah

Avlayah is a prescription intravenous therapy used to treat neurological manifestations of Hunter syndrome (MPS II), a rare genetic disorder caused by enzyme deficiency leading to harmful substrate accumulation.

Unlike traditional enzyme replacement therapies, Avlayah is designed to cross the blood–brain barrier, allowing delivery of the functional enzyme to both the body and the brain, helping reduce disease burden.

Hunter syndrome can lead to progressive neurological decline and impact overall development and quality of life. Targeted therapies like Avlayah aim to slow progression and improve patient outcomes.

Avlayah is administered through regular intravenous infusions under medical supervision as part of a long-term treatment approach.

The information outlined in the molecule details section below would help you plan aBLA development early to enable a streamlined and competitive biosimilar strategy.

Molecule Details :

  • Molecule Name :

    Tividenofusp Alfa-Eknm
  • Innovator :

    DENALI THERAPEUTICS INC
  • Approval Date :

    24-Mar-26
  • Data Exclusivity Expiry :

    24-Mar-30
  • Market Exclusivity Expiry :

    24-Mar-38
  • Dosage Form :

    Injection
  • Strength :

    150MG/VIAL
  • Therapeutic Category :

    Enzyme Replacement Therapy
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    NA
  • 2026 :

    12
  • 2027 :

    60
  • 2028 :

    127
  • 2029 :

    193
  • 2030 :

    264
  • 2031 :

    330
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