Response to FDA Safety Alert Regarding the Use of Fecal Microbiota for Transplantation

Response to FDA Safety Alert Regarding the Use of Fecal Microbiota for Transplantation
June 14, 2019 rupalivakils
PRESS RELEASE 2019

Response to FDA Safety Alert Regarding the Use of Fecal Microbiota for Transplantation

Parsippany, New Jersey – 14 June 2019 – Rebiotix and Ferring Pharmaceuticals were saddened to learn about the patients mentioned in the FDA’s safety alert regarding the use of Fecal Microbiota for transplantation and risk of serious adverse reactions due to transmission of multi-drug resistant organisms*. We do not have any details regarding the patients mentioned in the safety alert, as they were not enrolled in our clinical trials.  Our thoughts are with their families. These unfortunate events reinforce our commitment to bringing safe and effective FDA-approved products to market.

We are aligned with and remain committed to the FDA’s additional protections as outlined in the safety alert. Rebiotix and Ferring are strong proponents of the appropriate screening of donor derived microbiota products as a means to avoid a public health incident, as described in the FDA safety alert. Rebiotix was the first company to engage the FDA in defining a regulatory pathway for microbiota-based therapies. We continue to work closely with the FDA to sponsor high quality clinical trials with stringent donor screening programs, as we conduct our fourth clinical trial on our lead candidate RBX2660.

About Rebiotix

Rebiotix Inc., part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionise the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The MRT platform is a standardised, stabilised drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. The lead drug candidate, RBX2660, is currently in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the US FDA for its potential to prevent recurrent C. diff infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized, non-frozen, oral capsule part of a recently completed investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff infection. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, women’s health, urology, gastroenterology, endocrinology, oncology, and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com

For more information, please contact

Courtney Jones                                                     
(651) 705-8774
cjones@rebiotix.com

Peter Dannenfelser
(973) 832-2304
peter.dannenfelser@ferring.com

* https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse

 

GIMK/1631/2019/US

This page is not intended for patients or for members of the general public. It is only intended to be used by healthcare professionals.

OK

Cette page n'est pas destinée aux patients ou au grand public. Il est uniquement destiné à être utilisé par des professionnels de santé.

OK

Ik bevestig dat ik een professionele zorgverlener ben of een zakelijke relatie heb met Ferring Pharmaceuticals

OK

Ez az oldal nem betegeknek, vagy nagyközönségnek szól. Az oldalt kizárólag egészségügyi szakemberek használhatják.

OK

Ta strona nie jest przeznaczona dla pacjentów ani dla ogółu odwiedzających. Ta strona stworzona jest dla pracowników sektora ochrony zdrowia.

OK

Эта страница не предназначена для пациентов или для широкой публики. Она предназначена только для медицинских работников.

OK