Tanabe’s positive results bring life to EPP and XLP patients

Introduction

Tanabe Pharma America, Inc., formerly Mitsubishi Tanabe Pharma America, is a U.S. division of Japan’s Tanabe Pharma Corporation. The company is known for its marketing skills and introducing treatments for extreme areas of rare diseases, immune-inflammation and CNS. The company’s science-driven innovation is a healing pill for patients seeking effective and affordable treatments. Since 2016, the company has been promoting its old but gold groundbreaking innovations through its parent company.

Announcement

Tanabe Pharma America, Inc. unveiled its safety and efficacy results from the INSPIRE study, a Phase 3 clinical trial of dersimelagon (MT-7117). This agonist is discovered for the oral treatment of X-linked protoporphyria (XLP) and erythropoietic protoporphyria (EPP) patients for both adults and adolescents.

What are EPP and XLP disorder?

The XLP and EPP is a disorder of the heme biosynthetic pathway that can be transferred from any family member, as its hereditary case. It’s visible in the unbearable pain when exposed to sunlight or any other artificial light. In Europe, 1 in 200,000 and 1 in 75,000 of the population have EPP.

Head of Global Development and Regulatory Affairs, Bijan Nejadnik, said, “Treatment options are very limited for XLP or EPP and have no such qualified treatment for adolescents as well. This has adversely affected patient care and continues to be disturbed by this irritation. Only one option for prevention or sun protection is approached by most of the individuals. These new promising results from the ISNPIRE study mark a major milestone that will navigate and support our research for the porphyria population.”

INSPIRE study and Tanabe’s dedication

This powerpact INSPIRE study is a placebo-balanced Phase 3 clinical trial checking safety, tolerability and efficacy of dersimelagon in EPP and XLP patients covering 16 week treatment timeframe. Under this study, the eligible participants were shuffled to either the active treatment group or the placebo group after the 36-week expansion timeframe of active treatment.

This study initially assessed the test, which is prodromal symptoms, incorporating sunlight exposure. Apart from this few of the adverse scenarios were general in nature; the open-label expansion is in the lane. Tanabe is dedicated to assessing creative products, meeting the market standards and needs of the patient group. The company is confident enough regarding its recent positive results, followed by dersimelagon’s Fast Track Designation by the U.S. FDA in 2018 and an ODD honor in June 2020. The official approval is awaited.