FDA approves label extension for ITF Pharma Tiglutik

The US Food and Drug Administration (FDA) has approved the application to broaden the existing label for Tiglutik (riluzole) oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of amyotrophic lateral sclerosis (ALS).

This supplemental New Drug Application (sNDA), filed by Italfarmaco’s US subsidiary ITF Pharma, expands the patient population who stand to benefit from Tiglutik to include individuals whose swallowing difficulty is complicated by alterations in nutritional status, necessitating the use of a PEG feeding tube.

Around 20,000 Americans are living with ALS. Difficulty swallowing, medically referred to as dysphagia, afflicts 85% of people with ALS during the course of their disease. Due to these challenges, many patients require the placement of a PEG tube, which allows nutrition, fluids and medications to be put directly into the stomach, bypassing the mouth and esophagus.