A generic form of teduglutide, Teduglutide Viatris (Viatris Limited), that cuts parenteral nutrition needs in patients with short-bowel syndrome (SBS) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use.

The therapy is intended for patients aged 4 months corrected gestational age or older who are clinically stable after intestinal adaptation following major small-bowel resection.

What Is SBS?

SBS is a rare, life-threatening condition that results from extensive surgical resection of the small intestine. The loss of intestinal surface area leads to malabsorption of nutrients, fluids, and electrolytes, which can lead to intestinal failure. 

Patients with severe SBS cannot maintain adequate nutrition or hydration through oral intake alone and become dependent on parenteral support via intravenous fluids. 

The goal of treatment, including therapies such as subcutaneous teduglutide, is to enhance the remaining intestine’s absorptive capacity (a process called intestinal adaptation) to reduce or eliminate the need for parenteral support.

How the Treatment Works

Teduglutide Viatris is a generic version of Revestive, the original teduglutide formulation authorized in the EU since 2012. Teduglutide works as a glucagon-like peptide 2 analog that promotes intestinal adaptation by increasing intestinal and portal blood flow, reducing gastric acid secretion, slowing intestinal motility, and supporting mucosal growth (increased villus height and crypt depth). 

Because subcutaneous teduglutide achieves 100% bioavailability, the European regulator did not require a bioequivalence study vs the reference product. Studies showed satisfactory quality of the generic formulation compared with the original medication.

Teduglutide Viatris will be available as a 5-mg powder and solvent for solution for injection, administered subcutaneously. 

Reducing Parenteral Support

In a pediatric study, 25 children (median age, 9.4 years) who had been dependent on parenteral nutrition for a median of 8 years received subcutaneous teduglutide at 0.05 mg/kg daily for 48 weeks. The results showed that 96% of the children experienced greater than 20% reduction in parenteral nutrition requirements by week 24. 

Another multicenter trial evaluated different doses of teduglutide in 42 children, showing that higher doses of 0.025 and 0.05 mg/kg daily produced more substantial reductions in parenteral nutrition volume and calories compared with lower doses or standard care alone. 

The most common adverse events associated with teduglutide include temporary abdominal discomfort during early treatment phases, injection site reactions, and minor stoma changes in patients with ostomies.

Detailed recommendations for product use will be described in the Summary of Product Characteristics, which will be published on the EMA website in all EU languages after the European Commission grants marketing authorization.