Bristol Myers Squibb's Oral TYK2 Inhibitor Deucravacitinib Under Regulatory Review in U.S., EU, and Japan for Moderate-to-Severe Plaque Psoriasis, Demonstrating Superior Efficacy Over Otezla
Dec 14, 2021 01:40
CST Updated
01:40
Bristol-Myers Squibb
Biopharmaceutical and Nutritional Product R&D and Sales
FDA
U.S. Food and Drug Administration
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
Plaque Psoriasis (Image Source: dermatologyadvisor.com)
December 13, 2021 /BioValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have respectively acceptedAnti-inflammatory Drug TYK2 Inhibitor DeucravacitinibNew Drug Application (NDA) and Marketing Authorization Application (MAA): ForTreatment of adult patients with moderate to severe plaque psoriasis (PsO)。FDAThe NDA's "Prescription Drug User Fee Act (PDUFA)" target date has been set for September 10, 2022. Additionally, Japan's Ministry of Health, Labour and Welfare (MHLW) has also accepted the NDA for deucravacitinib for the treatment of adult patients with moderate to severe plaque psoriasis, pustular psoriasis, and erythrodermic psoriasis.
Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action that inhibits IL-12, IL-23, and type 1 interferon pathways.This drug is the first TYK2 inhibitor in clinical research evaluation for the treatment of multiple immune-mediated diseases.
Deucravacitinib Chemical Structure (Source: genome.jp)
The regulatory application for deucravacitinib is based on two pivotal Phase 3 trials.Clinical TrialPositive results from the POETYK PSO-1 and POETYK PSO-2 trials. These two trials were conducted in adult patients with moderate to severe plaque psoriasis, comparing deucravacitinib (6mg, once daily oral administration) with placebo and Otezla (apremilast, 30mg, twice daily).
The results showed that both trials met the co-primary endpoints and secondary endpoints:Deucravacitinib showed significant and clinically meaningful improvements in skin clearance, symptom burden, and quality of life compared to placebo and Otezla., including a significantly higher proportion of patients achieving at least 75% relative improvement in the Psoriasis Area and Severity Index (PASI75) from baseline compared to placebo and Otezla at Week 16, static Physician's Global Assessment (sPGA) scores indicating complete or almost complete skin clearance (sPGA 0/1), and a higher proportion of patients achieving PASI75 and sPGA 0/1 compared to Otezla at Week 24, which was maintained up to Week 52. In this study, deucravacitinib demonstrated good safety and tolerability with a low rate of discontinuation due to adverse events and no clinically meaningful laboratory abnormalities.
Jonathan Sadeh, Senior Vice President of Immunology and Fibrosis Development at Bristol-Myers Squibb, stated: "There is an urgent need for more effective and better-tolerated oral therapies for patients with moderate to severe plaque psoriasis, as many patients remain either undertreated or untreated. The results from the two pivotal Phase 3 POETYK-PSO trials demonstrate that deucravacitinib has the potential to raise the standard of oral care for patients suitable for systemic treatment. We look forward to continuing to work with...FDA"In collaboration with EMA, we aim to bring deucravacitinib to patients and doctors as soon as possible." (Bioon.com)