FDA approves new treatment for ALS sufferers like Dwight Clark

FDA approves new treatment for ALS sufferers like Dwight Clark

Patients with the chronic neurodegenerative disease amyotrophic lateral sclerosis (ALS) have a new treatment option in the USA after the FDA approved Mitsubishi Tanabe Pharma's Radicava (edaravone). Following approval in 2015, Radicava retails for $35,000 in Japan, where all prescription drug prices are reviewed and potentially cut each year.

People who have ALS now have an alternative to the original treatment as the FDA approved a new drug.

The FDA said the drug's efficacy was demonstrated in a six-month trial in Japan, which had enrolled 137 patients who were randomized to edaravone or placebo.

The producer of the drug, MT Pharma, mentioned that this new drug could slow the physical function decline by more than 30%.

Dr. Eric Bastings, the deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said the agency quickly encouraged the drugmaker to file to make the drug available in the U.S. "The approval of RADICAVA gives great promise for what we hope will be the first of many new treatments", said Barbara Newhouse, President and CEO, ALS Association.

ALS is a progressive neurodegenerative condition which affects the nerve cells in the spinal cord and the brain. The nerves lose the ability to activate specific muscles, which causes the muscles to become weak and leads to paralysis. At least 12,000 Americans have ALS, and most die less than five years after symptoms start appearing. "I'm very happy, frankly, that there is a second drug approved for ALS".

The ALS Association, a non-profit organization, was pleased to learn about the FDA's approval. That's obviously a much larger market, compared with the rare-disease status of ALS. "We recognize how important this therapy may be to people with ALS and are committed to helping provide access to this important treatment option, with the goal of keeping out-of-pocket costs at a minimum for eligible patients". After the rest, the patients' Radicava infusion will be given daily for 10 out of 14 days, with 14 days off. This drug was approved in Japan for ALS treatment after having a four-year clinical trial. Doctors usually don't know why ALS occurs.

Radicava is an intravenous infusion that must be prescribed by a doctor and is administered in 28-day cycles.

Radicava's ride to the US market is a bit of an unusual one. Its makers said it intends to work with patients whose health insurance plans that require significant copayments to lower the out-of-pocket cost.

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