- In June 2024, Mitsubishi Tanabe Pharma Corporation transferred its European argatroban business to Ethypharm. This strategic move allows Mitsubishi Tanabe to focus on Radicava, an advanced treatment agent for ALS, and enhance its presence in the European market for rare diseases, particularly in neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS)
- In June 2024, The FDA announced a new funding opportunity under the FDA Rare Neurodegenerative Disease Grant Program. This initiative is designed to support clinical studies and research focused on ALS and other neurodegenerative diseases. It aims to accelerate the development of innovative treatments for these life-altering conditions, benefiting patients and healthcare systems
- In February 2024, Biogen’s QALSODY, a groundbreaking SOD1-ALS therapy, received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products. This regulatory milestone marks a significant step in the approval process for QALSODY, which is designed to treat a specific genetic mutation in ALS patients, offering hope for targeted treatment options
- In April 2023, Biogen’s QALSODY (tofersen), a first-of-its-kind SOD1-ALS therapy, received accelerated approval from the FDA for the treatment of SOD1-ALS. This approval represents a major advancement in ALS treatment, marking QALSODY as the third targeted drug approved for this rare and devastating condition, providing new hope for patients with this specific genetic mutation
- In March 2022, Aquestive Therapeutics entered into a licensing agreement with Haisco Pharmaceutical Group to supply Riluzole oral film in China. This partnership aims to expand the availability of Riluzole, an important drug in managing ALS, to Chinese patients, leveraging Aquestive's innovative oral film technology for better adherence and patient outcomes
- In January 2021, Aquestive Therapeutics signed license and supply agreements with Mitsubishi Tanabe Pharma America to distribute EXSERVAN in the U.S. EXSERVAN, a unique oral film formulation of riluzole, provides an alternative delivery method for ALS patients. This agreement strengthens the accessibility of EXSERVAN and enhances patient adherence to ALS treatment regimens in the U.S.
