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Date: 2018-01-08

Type of information: Granting of the Breakthrough Therapy status

Product name: upadacitinib (ABT-494)

Compound: upadacitinib

Therapeutic area: Autoimmune diseases - Dermatological diseases

Action mechanism:

  • JAK inhibitor/tyrosine kinase inhibitor. Upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of immune-mediated disorders. It has been discovered and developed by AbbVie.

Company: Abbvie (USA - IL)

Disease: atopic dermatitis

Latest news:

  • • On January 8, 2018, AbbVie announced the FDA granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. This Breakthrough Therapy Designation is supported by positive Phase 2b results previously announced in September 2017.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes