Avid Bioservices Inc (CDMO)

[biopharm]

There are many Subcutaneous BLAs pending ...Avid CDMO stands to pick up and lock in the manufacturing ....and those smart enough to lock in (as some already have will have PRIORITY when PS Targeting gets approval ) stand to be able to have the advantage to get even quicker FDA approvals based on PS Targeting

FDA accepts application for subcutaneous Entyvio for ulcerative colitis
May 10, 2019
...
..

The proposal — which would make Entyvio available in pre-filled syringes and pens — is based on the positive results from the phase 3 VISIBLE 1 trial that was presented at UEG Week 2018.
....
....
Having subcutaneous vedolizumab for the maintenance of remission of ulcerative colitis is an exciting proposition. The VISIBLE 1 trial showed us that the subcutaneous formulation is at least as effective as the intravenous formulation at maintaining remission and more effective than placebo.

An additional method of delivery would give physicians a lot more flexibility and be more convenient for some patients. A lot of patients would prefer to self-administer an injection every 2 weeks, as opposed to coming into an infusion center every 8 weeks. They would be able to do it at home and prevent having to take off from work or other activities.

Adam Cheifetz, MD
Director
Center for Inflammatory Bowel Disease
Beth Israel Deaconess Medical Center

https://www.healio.com/gastroenterology/inflammatory-bowel-disease/news/online/%7B0e81d182-9067-42fc-b513-82d1c45b802d%7D/fda-accepts-application-for-subcutaneous-entyvio-for-ulcerative-colitis

Subcutaneous Formulation of Takeda’s Entyvio Hits the Mark in Crohn’s Trial

Published: Jul 22, 2019

...
...

Takeda Pharmaceutical’s Phase III Crohn’s disease trial evaluating an investigational subcutaneous formulation of Entyvio (vedolizumab) as a maintenance therapy for patients with moderately or severely active disease hit the mark, the company announced this morning.
...
...

Asit Parikh, head of Takeda’s Gastroenterology Therapeutic Area Unit, said hitting the primary endpoint of the VISIBLE 2 study “marks a crucial step in our efforts to help patients with Crohn’s disease as to how they may receive treatment with vedolizumab.” Data from the VISIBLE 2 trial, alongside VISIBLE 1, which assessed the subcutaneous version of Entyvio in ulcerative colitis, provides a “more comprehensive picture” of the new formulation as a maintenance therapy, Parikh said. Both ulcerative colitis and Crohn’s disease are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract that are often progressive in nature.

The VISIBLE 1 study demonstrated the subcutaneous version of Entyvio generated a 46.2% clinical remission rate in ulcerative colitis patients at week 52. That was in comparison to a 14.3% response for placebo. In May, the U.S. Food and Drug Administration accepted Takeda’s Biologics License Application for the subcutaneous formulation of Entyvio as a maintenance therapy for ulcerative colitis based on the VISIBLE 1 study. Takeda said it plans to make the subcutaneous formulation available in both pre-filled syringe and pen options.
....

https://www.biospace.com/article/subcutaneous-formulation-of-takeda-s-entyvio-hits-the-mark-in-crohn-s-trial/

______________


a