FDA approval

Note: This story was updated Sept. 30, 2022, to correct the spelling of Albrioza and clarify the FDA advisory committee voted in March that the evidence from CENTAUR was not sufficient to support Relyvrio’s efficacy in ALS. It also added Relyvrio’s list price is set at about $158,000 per year.

Brainstorm Cell Therapeutics is preparing to file an application with the U.S. Food and Drug Administration (FDA) requesting approval of its cell-based therapy NurOwn for amyotrophic lateral sclerosis (ALS). The decision to submit a biologics license application was based on “the totality of the evidence from NurOwn’s clinical…

The U.S. Food and Drug Administration (FDA) has approved Mitsubishi Tanabe Pharma America (MTPA)’s oral suspension formulation of edaravone, Radicava ORS, for the treatment of amyotrophic lateral sclerosis (ALS). The oral therapy is designed to offer the same efficacy as MTPA’s Radicava (edaravone) — an FDA-approved, into-the-vein therapy…

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Prilenia’s pridopidine for the treatment of amyotrophic lateral sclerosis (ALS). The decision follows a recent positive opinion from a branch of the European Medicines Agency recommending the treatment be given orphan drug status in…

The U.S. Food and Drug Administration has agreed to expand Tiglutik, a liquid oral form of riluzole, to include giving it via a feeding tube to treat amyotrophic lateral sclerosis (ALS), ITF Pharma, the company marketing Tiglutik, announced. The approval of administering the therapy via percutaneous endoscopic…

A dissolving oral film form of riluzole, called Exservan and able to be taken by amyotrophic lateral sclerosis (ALS) patients without a need for water, has been approved by the U.S. Food and Drug Administration (FDA). Riluzole was the first ALS treatment, approved by the FDA over two decades…

Awareness Breeds Compassion. Compassion Drives Enhanced Funding. Funding Generates Heightened Innovative Intervention Ideas. It all starts with awareness. May is ALS Awareness Month. It is not a coincidence that I chose three words beginning with the letter “I.” I believe that a single measure of awareness yields…

Xeomin (incobotulinumtoxinA) has been approved by the U.S. Food and Drug Administration for the treatment of chronic sialorrhea, or excessive drooling, a common condition in amyotrophic lateral sclerosis (ALS) patients. Merz Neurosciences, a division of Merz North America, recently announced that its supplemental biologics license application (sBLA) for Xeomin was…

The U.S. Food and Drug Administration has expanded its approval of Dysport (abobotulinumtoxinA) as a  treatment for spasticity in adults from not just the upper limbs but to the lower limbs as well, according to its maker, Ipsen Biopharmaceuticals. Spasticity can affect those with amyotrophic lateral sclerosis (ALS), multiple sclerosis, cerebral…

Radicava, also known by its generic name edaravone, is the first treatment approved by U.S. Food and Drug Administration (FDA) in more than two decades to help amyotrophic lateral sclerosis (ALS) patients. While awaiting its arrival, ALS News Today spoke to the company responsible for its U.S. launch,…