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AVLAYAH (TIVIDENOFUSP ALFA-EKNM)
AVLAYAH (generic name: TIVIDENOFUSP ALFA-EKNM) is a drug developed by DENALI THERAPEUTICS INC.. It is currently FDA-approved.
AVLAYAH is a protein modality with synonyms including DNL-310, DNL310, ETV:IDS, and TIVIDENOFUSP ALFA.
At a glance
| Generic name | TIVIDENOFUSP ALFA-EKNM |
|---|---|
| Sponsor | DENALI THERAPEUTICS INC. |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies, including AVLAYAH, have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate AVLAYAH in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue AVLAYAH and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1) ] . WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. ( 5.1 ) Initiate AVLAYAH in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. ( 5.1 ) If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue AVLAYAH and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 )
Common side effects
- Infusion-associated reaction
- Upper respiratory tract infection
- Ear infection
- Pyrexia
- Anemia
- Cough
- Vomiting
- Diarrhea
- Rash
- COVID-19
- Rhinorrhea
- Nasal congestion
Serious adverse events
- Anaphylaxis
- Membranous nephropathy
- Severe infusion-associated reaction
- Severe anemia
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AVLAYAH CI brief — competitive landscape report
- AVLAYAH updates RSS · CI watch RSS
- DENALI THERAPEUTICS INC. portfolio CI
Frequently asked questions about AVLAYAH
What is AVLAYAH?
AVLAYAH (TIVIDENOFUSP ALFA-EKNM) is a pharmaceutical drug developed by DENALI THERAPEUTICS INC..
Who makes AVLAYAH?
AVLAYAH is developed and marketed by DENALI THERAPEUTICS INC. (see full DENALI THERAPEUTICS INC. pipeline at /company/denali-therapeutics-inc).
What is the generic name of AVLAYAH?
TIVIDENOFUSP ALFA-EKNM is the generic (nonproprietary) name of AVLAYAH.
What development phase is AVLAYAH in?
AVLAYAH is FDA-approved (marketed).
What are the side effects of AVLAYAH?
Common side effects of AVLAYAH include Infusion-associated reaction, Upper respiratory tract infection, Ear infection, Pyrexia, Anemia, Cough. Serious adverse events: Anaphylaxis, Membranous nephropathy, Severe infusion-associated reaction, Severe anemia.
Related
- Manufacturer: DENALI THERAPEUTICS INC. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing