Takeda reports second PhIII win for subcutaneous Entyvio as regulators review expanded use
Before consummating its $62 billion buyout of Shire, Takeda divested SHP647 — which the rare disease biotech was developing for ulcerative colitis — so it can retain its blockbuster drug Entyvio. In doing so the Japanese pharma took the opposite approach to Bristol-Myers, which found itself in a similar predicament but chose to bet on its own investigational drug over Celgene’s Otezla — a top seller that’s just expanded its label.
That strategy seems to be paying off for Takeda, which has reported positive results for a Phase III study testing the subcutaneous formulation of the drug, also known as vedolizumab, as a maintenance therapy.
Conducted over a year, the VISIBLE-2 trial recruited patients with moderately to severely active Crohn’s disease that is insufficiently controlled by current treatments — from corticosteroids and immunomodulators to tumor necrosis factor-alpha (TNFα)-antagonists. Researchers first dosed all 644 participants with the intravenous Entyvio, then took those who achieved clinical response at week 6 and gave them subcutaneous injections of either drug or placebo for another 44 weeks.
A statistically significant proportion of patients on SC vedolizumab achieved clinical remission over placebo, Takeda said with breaking out the numbers, meeting the primary endpoint of the trial.
It’s a crucial step in expanding the dosing options for Entyvio, which blocks the binding of α₄β₇ integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), thereby ameliorating the inflammatory effect of white blood cells on gut tissues. To be presented at later conferences and submitted to regulators, the data add to results from an earlier trial confirming similar effects for ulcerative colitis, Asit Parikh, Takeda’s gastroenterology head, said in a prepared statement.
Both the FDA and EMA have accepted the applications for subcutaneous Envytio for review.
Entyvio generated around $2.5 billion in sales in the fiscal year ending March 2019, according to filings. That’s a third more than the previous year, marking it as a key growth product for the company.