Therapy Areas: Vaccines
Ferring Announces US FDA Advisory Committee Meeting for RBX2660 its Investigational Microbiota-Based Live Biotherapeutic
9 August 2022 - - The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration will hold a meeting on September 22, 2022, to review data supporting the biologics license application for RBX2660, a microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection after antibiotic treatment, Switzerland-based Ferring Pharmaceuticals said.

The FDA intends to live stream the advisory committee meeting on the agency's YouTube page, and the meeting will also be webcast from the FDA website.

C. difficile infection is a serious and potentially deadly disease that impacts people across the globe. The C. difficile bacterium causes debilitating symptoms such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis (an inflammation of the colon).

Declared a public health threat by the US Centers for Disease Control and Prevention requiring urgent and immediate action, CDI causes an estimated half a m illnesses and tens of thousands of deaths in the US alone each year.

C. difficile infection can be the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.

It has been estimated that up to 35% of CDI cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further infections.

After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.

RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection after antibiotic treatment.

RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the US.

Food and Drug Administration. RBX2660 was developed by Rebiotix, a Ferring company.

Ferring Pharmaceuticals is a research driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives.

Headquartered in Saint-Prex, Switzerland, Ferring is in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth.

Founded in 1950, privately owned Ferring now employs around 6,000 people worldwide, has its own operating subsidiaries in more than 50 countries, and markets its products in 110 countries.

Ferring is committed to exploring the crucial link between the microbiome and human health, beginning with the threat of recurrent C. difficile infection.

Ferring is working to develop novel microbiome-based therapeutics to address significant unmet needs and help people live better lives.
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