US FDA approves the first treatment for amyotrophic lateral sclerosis

Recently, the US FDA announced the approval of MT Pharma America's new drug Radicava (edaravone) for the treatment of Amyotrophic Lateral Sclerosis (ALS), the first ALS therapy approved by the FDA for 22 years.

ALS, also known as Lou Cehrigs disease, was first diagnosed in 1869 by Jean-Martin Charcot, an irreversible lethal motor neuron disease. The lesion mainly invades the upper motor neurons (brain, brainstem, spinal cord), and affects the chronic motor neuron (cranial nucleus, spinal cord anterior horn cells) and its dominant trunk, limbs and head and face muscles. A rare disease, the world famous physicist Stephen Hawking is suffering from the disease.

According to estimates by the Centers for Disease Control and Prevention, there are approximately 1,200-1,5000 ALS patients in the United States who are unable to control specific muscles due to damaged or dead nerve cells (the muscles can move freely, such as chewing). , walking, breathing, and talking), causing the muscles to become weak and eventually paralyzing the patient. Due to the progressive nature of the disease, the patient's symptoms will continue to worsen, and most patients will die from respiratory failure within 3-5 years of the first appearance of the symptoms.

On July 29, 2014, an event called “Ice Bucket Challenge” became popular around the world. The event aims to attract more people to pay attention to ALS and bring more treatments and hopes to patients suffering from the disease. In less than a month, the Ice Bucket Challenge raised $13.3 million for the American Society of Amyotrophic Lateral Sclerosis.

It is understood that oxidative stress is a very likely factor in the onset and progression of ALS, while Radicava is a free radical scavenger that can alleviate the effects of oxidative stress. Radicava was approved for marketing in Japan and South Korea in 2015 to treat ALS, FDA drugs. Eric Bastings, deputy director of the Department of Neurology Products at the Center for Evaluation and Research, said: After hearing that Radicava was listed in Japan, the FDA quickly approached drug developers to discuss the application for US listing. This is the first time the US FDA has approved the treatment of ALS. With new therapies, we are happy to give ALS patients a choice. Previously, Radicava was awarded the orphan drug status by the US FDA.

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