Deucravacitinib: First Approval

Area of Science:

• Immunology
• Pharmacology
• Dermatology

Background:

• Deucravacitinib is a first-in-class, selective oral inhibitor targeting tyrosine kinase 2 (TYK2).
• It functions through an allosteric mechanism, stabilizing an inhibitory interaction within the TYK2 enzyme.
• Bristol Myers Squibb is developing deucravacitinib for various immune-mediated diseases.

Purpose of the Study:

• To summarize the development milestones of deucravacitinib.
• To highlight its first approval for treating adults with moderate-to-severe plaque psoriasis.

Main Methods:

• Review of deucravacitinib's development pathway.
• Analysis of regulatory approvals and clinical development status.

Main Results:

• Deucravacitinib received US FDA approval on September 9, 2022, for plaque psoriasis.
• Japan approved deucravacitinib for plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis on September 26, 2022.
• Marketing Authorisation Application validated in the EU for moderate-to-severe plaque psoriasis.

Conclusions:

• Deucravacitinib represents a significant therapeutic advancement for plaque psoriasis.
• The drug's development is progressing for broader immune-mediated disease applications.
• This article details the journey to deucravacitinib's initial regulatory successes.