ALS Texas

Frequently Asked Questions about Radicava™ (Edaravone)

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Based on information as of 5/5/2017

What is Radicava?

Radicava™ (edaravone) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat people with amyotrophic lateral sclerosis (ALS).1

In clinical trials, some people given Radicava showed significantly less decline in physical function compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in patients with ALS.1,2

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FDA Approves New ALS Drug

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Radicava is First Approved Treatment for ALS in Decades

The Food and Drug Administration’s (FDA) announced today that it has approved Radicava (edaravone), the first new treatment approved specifically for ALS in 22 years. The FDA approved Radicava less than a year after Mitsubishi Tanabe Pharma Corporation submitted a New Drug Application. The only other approved treatment specifically for ALS, riluzole, was approved in 1995.

“We thank the FDA and MT Pharma for working together to expedite the approval of the first new ALS-specific treatment in decades,” said Barbara Newhouse, president and CEO of The ALS Association. “We hope today’s announcement signals the beginning of a new chapter in the fight against this terrible disease. There are several drugs to treat ALS currently in clinical trials and we are hopeful that people living with ALS have even more therapies available to them sooner rather than later.”

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Dr. Appel and the ALS Association Partner to Expand Multidisciplinary Care in Texas

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Appel Clinic

Today, the ALS Association invested $50,000 into the Houston Methodist ALS Clinic led by neurologist Stanley H. Appel, MD, and recognized it as an ALS Association Certified Treatment Center of Excellence.

Dr. Appel has had a long-standing partnership with the Muscular Dystrophy Association and the collaboration among the three entities aims to provide top notch care to people with ALS, as well as provide maximum resources to patients and families. Many regular clinic patients were already turning to both MDA and the ALS Association for services. Dr. Appel’s top priority is the patient and making sure he or she has everything he or she needs, so when the opportunity arose for ALS Texas to partner with the Houston Methodist ALS Clinic, Dr. Appel agreed that it would be best for the patient.

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ALS BrainStorm Stem Cell Clinical Trials Update

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JAMA Neurology has published a paper titled, “Safety and Clinical Effects of Mesenchymal Stem Cells Secreting Neurotrophic Factor Transplantation in Patients With Amyotrophic Lateral Sclerosis – Results of Phase1/2 and 2a Clinical Trials.” This study comes out of a collaboration of researchers from BrainStorm Cell Therapeutics and the Hadassah-Hebrew University Medical Center both located in Israel.

The researchers set out to understand the safety and clinical effects of treatment with mesenchymal stem cells induced to secrete neurotrophic factors (MSC-NTF) in patients with ALS. Stem cells used in this study are adult mesenchymal stem cells derived from bone marrow samples given by participants in the trial. The bone marrow cells are turned into stem cells that secrete the NTFs. NTFs are a type of nutrient for cells and were previously shown to have protective effects in animal models of neurodegenerative disease.

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ALS Association Awards $1.3M to 9 New ALS Research Projects

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We are excited to announce funding for  nine new ALS research projects! The ALS Association awarded more than $1.3M to projects across the country, furthering investigation into the cause, treatments and cure for ALS.  Projects include research on the C9orf72 gene, which has been identified as the most common cause of familial ALS.  The research awards include ALS Association-Initiated Grants, Investigator-Initiated Biomarker Grants, and the Milton Safenowitz Postdoctoral Fellowships.

To learn more about these research grants and initiatives, visit alsa.org.