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FDA approves ITF Pharma’s Tiglutik for ALS

IFT Pharma has received the green light from the Food and Drug Administration for Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis. The product is the first and only easy-to-swallow thickened riluzole liquid for ALS and is administered twice daily via an oral syringe, according to the company.

ALS, also known as Lou Gehrig's disease, is a progressive, ultimately fatal neurodegenerative disease, marked by a gradual degeneration of nerve cells of the central nervous system that control voluntary muscle movement.

"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," Wesley J. Howe professor of neurology at Columbia University at The Neurological Institute of New York and New York-Presbyterian Hospital/Columbia University Medical Center Hiroshi Mitsumoto said, in a press statement."The availability of TIGLUTIK oral 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 ITF Pharma for working together to bring this important new formulation of riluzole to the ALS community,” ALS Association president and CEDO Calaneet Balas said, in a statement.

"We are very pleased with the FDA approval of Tiglutik and we look forward to making the first and only easy-to-swallow thickened riluzole liquid for ALS commercially available in the U.S. in mid-October through our highly-specialized field sales team," ITF Pharma CEO Denny Willson said, in a statement. "ITF is committed to supporting the ALS community and to helping people living with ALS find affordable 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."

Tiglutik was approved under FDA fast-track designation, which expedites the review of drugs that have the potential to treat serious conditions and fill an unmet medical need. Tiglutik has received orphan drug designation from the FDA.
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