The first new drug for the treatment of ALS in 20 years approved in the United States

Radicava is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Photo: Bloomberg (representative image)

WASHINGTON: The first adoption of a new drug for the treatment of patients with amyotrophic lateral sclerosis (ALS) in two decades in the United States.

And it was given the US Food and Drug Administration last week to accept Radriqava (Aydaravon) for the treatment of multiple sclerosis known as Lou Gehrig's disease. ALS is a rare disease that attacks and destroys nerve cells that control voluntary muscles.

"After learning about the use of the drug" Aadaravon "for the treatment of ALS in Japan, said Eric Bastngs, deputy director of the Department of Neurology products in the evaluation of the drug center in the Food and Drug Administration, We have quickly shared with the pharmaceutical developer about the marketing of applications in the United States. " And research. "This is the first new FDA approved treatment for Alicia in the country for many years, we are happy that people with ALS will now be an additional option," said Bastngs.

In ALS, voluntary muscles produce movements such as chewing, walking, breathing, and talking. Losing the ability of nerves to activate specific muscles, leading to muscle weakness and lead to paralysis. Als progressive, meaning they are getting worse over time.

Estimates that the United States Centers for Disease Control and Prevention (CDC) that around 12,000 to 15,000 have ALS disease. Most people who suffer from Als disease die from respiratory failure, usually within three to five years from when symptoms first appear.

Radriqava is an intravenous infusion by a health care specialist, according to the FDA. Administered with the initial treatment cycle of daily doses for 14 days, followed by a drug-free period for 14 days. Subsequent therapy sessions consist of 10 doses of 14 days, followed by a 14-day-free drug. The Aadaravon efficacy to treat ALS have been demonstrated in a clinical trial over a six-month period, conducted in Japan.

In the trial, 137 participants were randomly selected to receive Alaadaravon or placebo. 24 per week, individuals who received Adaravon less in the clinical evaluation of the performance of the day compared to those receiving placebo decreased, according to the US Food and Drug Administration.

The most common adverse reaction responses reported by participants in clinical trials receive Adaravon bruising (bruising) and walking disorder. The FDA said Radriqava also was associated with serious risks that require immediate medical attention, such as hives, swelling or difficulty breathing and allergic reactions in a bilateral sodium sulfite which is an element of this drug.