FDA approves Radicava, 49ers legend Dwight Clark may try new treatment

May 7, 2017

NFL, San Francisco 49ers

Former San Francisco 49ers wide receiver Dwight Clark runs onto the field before the start of the “Legends of Candlestick” flag football game Saturday, July 12, 2014, in San Francisco. The game between former San Francisco 49er greats and a team of former NFL stars captained by Hall of Famer Dan Marino is the final one to be played at Candlestick Park. The park, which opened in 1960 and was also the home of the San Francisco Giants baseball team until 1999, is slated for demolition in the next year. (AP Photo/Eric Risberg)

By: Ana Kieu

For the first time in more than two decades, the U.S. Food and Drug Administration recently approved a new drug for the treatment of amyotrophic lateral sclerosis (ALS). The FDA announced on Friday that Radicava, also known as edaravone, has been approved for use in the United States. The other only drug used to treat ALS is called Riluzone, which was approved in 1995.

Various tests conducted in Japan determined that ALS victims who received edaravone experienced a lower decline in their daily level of functioning compared to those who received a placebo. Edaravone creator MT Pharma said that the drug can reduce the decline of physical function by 33 percent.

Deputy director of the FDA’s neurology products division Eric Bastings said his federal agency learned about the use of edaravone to treat ALS in Japan and filed a marketing application with the drug developer. Bastings also mentioned that his agency was pleased that people with ALS have an addition treatment option.

ALS is often called Lou Gehrig’s disease. Gehrig was a well-known baseball player who retired on June 21, 1939, due to the condition. The New York Yankees retired his No. 4 and he became the first player in MLB history to receive that honor. He played for the Yankees as a first baseman from 1923 to 1939. He passed away in his home in the Riverdale neighborhood of The Bronx, New York, on June 2, 1941, at the age of 37.

In 2014, ALS returned to the spotlight, thanks to the ALS Ice Bucket Challenge. The campaign was all over social media. Many people posted videos of themselves dumping cold water on their heads. In just eight weeks, the ALS Association received $115 million dollars in donations. These donations helped fund important developments in ALS research.

The CDC says that 12,000 to 15,000 Americans have ALS. The majority of these sufferers first found out they had the disease between the ages of 55 and 75. For the most part, sufferers live two to five years after discovering they have it. Conversely, ALS is a little more common in men as opposed to women. Nobody knows what causes the disease, but 5% to 10% of all ALS cases emerge within families. People with ancestral ALS live an average of one to two years after symptoms appear.

ALS Association President Barbara Newhouse commended the approval of Radicava. Newhouse thanked the FDA and MT Pharma for working together to speed up the approval of the brand-new ALS treatment. She hopes the announcement can signal the beginning of a new chapter in the fight against the disease.

Radicava is an intravenous infusion that must be prescribed by a doctor. The drug is administered in 28-day cycles and its cost is $1,000 per infusion, which amounts to almost $150,000 a year for ALS treatment. MT Pharma will offer co-pay assistance for insured patients. They also mentioned an unnamed program to help help uninsured patients who meet certain requirements.

MT Pharma announced that Radicava will be available in the United States this August.

There has been no word from Clark yet on whether or not he’ll consider using edaravone. Clark was diagnosed with ALS on March 20. Edaravone can slow down the progression of ALS when started early. He has said in the past that he would fight like hell against ALS so there’s a chance he’ll use this new drug to battle his condition.

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