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avlayah

Generic: TIVIDENOFUSP ALFA-EKNM

avlayah: developed by 1 company · 1 FDA decision.

avlayah evidence translation

What we can confirm

What it means

Source-backed records connect avlayah to DNLI; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could avlayah → DNLI affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Development Pipeline (3)
CompanyPhase
Denali Therapeutics Inc. (DNLI)Approved
Denali Therapeutics Inc. (DNLI)Approved
Denali Therapeutics Inc. (DNLI)Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE AVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verifica(DNLI)FDA ↗
BLA761485Type 1 - New Molecular EntityOrphan DrugPriorityOtherInjection

Frequently asked questions

Who is developing avlayah?

avlayah is being developed by Denali Therapeutics Inc..

What is avlayah's latest FDA decision?

The most recent tracked FDA decision for avlayah is Approval for 1 INDICATIONS AND USAGE AVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verifica, dated March 24, 2026.