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avlayah

Generic: TIVIDENOFUSP ALFA-EKNM

avlayah: sourced relationships with 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

Dated Pipeline Records (3)
CompanyDated record stage
Denali Therapeutics Inc. (DNLI)
Reported 2026-03-24 · Current development: unknownSource
Approved
Denali Therapeutics Inc. (DNLI)
Reported 2026-03-24 · Current development: unknownSource
Approved
Denali Therapeutics Inc. (DNLI)
Reported 2026-03-24 · Current development: unknownSource
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 verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome. AVLAYAH is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme 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. ( 1 ) This indication is approved under accelerated approval based on reduction of cerebrospinal fluid heparan sulfate observed in patients treated with AVLAYAH. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies. ( 1 )(DNLI)FDA ↗
BLA761485Type 1 - New Molecular EntityOrphan DrugPriorityOtherInjection

Frequently asked questions

Which companies have sourced relationships with avlayah?

avlayah has dated SEC/FDA relationship records for 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 verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome. AVLAYAH is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme 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. ( 1 ) This indication is approved under accelerated approval based on reduction of cerebrospinal fluid heparan sulfate observed in patients treated with AVLAYAH. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies. ( 1 ), dated March 24, 2026.