Berwyn, Pa., Sept. 6, 2018–EDW Pharma, a U.S.-based specialty pharmaceutical company and a subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, committed to investing in and commercializing impactful medicines in therapeutic areas with unfulfilled needs, announced today that the U.S. Food and Drug Administration (FDA) has approved TIGLUTIK™ (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK is the first and only easy-to-swallow thickened riluzole liquid for ALS and is administered twice daily via an oral syringe.

“Having a therapeutic option designed to specifically overcome the challenges of disease-related dysphagia in ALS is a welcome step forward for the many doctors, caregivers and people living with ALS who have relied on riluzole as the gold standard of treatment for more than 20 years to slow the progression of this devastating disease,” said Hiroshi Mitsumoto, MD, DSc, Wesley J. Howe professor of neurology at Columbia University at The Neurological Institute of New York and NewYork-Presbyterian Hospital/Columbia University Medical Center. “The availability of TIGLUTIKoral suspension precludes the need for manipulation of tablets by patients or caregivers, easing administration and may provide an opportunity for more accurate dosing and enhanced patient compliance.”

“This approval marks an important step forward in the treatment of ALS. The ALS Association would like to thank the FDA and EDW Pharma for working together to bring this important new formulation of riluzole to the ALS community,” said Calaneet Balas, president and chief executive officer at The ALS Association.

“We are very pleased with the FDA approval of TIGLUTIKand we look forward to making the first and only easy-to-swallow thickened riluzole liquid for commercially available in the U.S. in mid-October through our highly-specialized field sales team,” said Denny Willson, chief executive officer of EDW Pharma. “ITF is committed to supporting the community and to helping people TIGLPA09/2018living with ALSfindaffordable access to TIGLUTIK. Therefore, we have partnered with a specialty pharmacy to create a simple and straightforward product support program that will help patients receive TIGLUTIK quickly and with ease. This reflects our underlying mission to provide valuable therapeutic options and support programs that make a positive difference in the lives of both patients and healthcare providers.”