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The new indication will allow the longtime ALS therapy to be used among the 85% of patients required to use PEG due to dysphagia.
The US Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for riluzole oral suspension (TIGLUTIK) as a treatment of amyotrophic lateral sclerosis (ALS) with a percutaneous endoscopic gastronomy (PEG) feeding tube.
The approval, granted to ITF Pharma, approves the existing label to include patients whose swallowing difficult is complicated by nutritional status alterations, thereby necessitating the use of a PEG feeding tube.
The therapy was originally approved and granted Orphan Drug Designation in 2018, projected to benefit the 85% of patients with ALS who develop dysphagia. The indication makes TIGLUTIK the only riluzole formulation marketed for both oral and PEG administration in patients with ALS.
The twice-daily therapy has been shown in pivotal trial data to repeatedly modulate glutamate neurotransmission by inhibition of signaling for both glutamate release and postsynaptic glutamate receptors.
Common adverse events associated with riluzole include oral hypoesthesia, asthenia, nausea, decrease lung function, hypertension, and abdominal pain. Investigators currently do not fully understand the drug’s mechanism of action.
About 20,000 Americans are living with ALS, of which there is no known cure. The expanded indication for the longtime ALS therapy is hugely beneficial for the majority patient subpopulation burdened with dysphagia.
“There are many medical and quality of life advantages for the use of a PEG feeding tube as an individual’s ALS progresses, including the ability maintain more adequate hydration, administer medications and to potentially reduce the risk of choking and aspirating when oral ingestion becomes too challenging,” Benjamin Rix Brooks, MD, medical director at the Carolinas Neuromuscular/ALS - MDA Center, said in a statement. “This expanded use for TIGLUTIK provides an alternate administration route for the majority of people with ALS who choose to undergo this procedure.”
Peter Cook, president and chief executive officer of ITF Pharma, said the company was very pleased with the broadened label for TIGLUTIK.
This news marks another important step forward in the treatment of ALS and addresses an unmet treatment need of the ALS community,” Cook said.