The Food and Drug Administration on Friday approved Mitsubishi Tanabe Pharma Corp's treatment for fatal neurological disorder amyotrophic lateral sclerosis (ALS), marking the first such U.S. regulatory approval in more than two decades.
The drug, known chemically as edaravone, has been sold by Japan-based Mitsubishi Tanabe in Japan and South Korea since 2015.
In the United States, the only other approved ALS medicine, generic riluzole, modestly slows the progression of the disease in some people.
After six months of treatment with edaravone on top of standard-of-care, data showed the intravenous drug reduced the rate of functional decline in patients by about a third, Dr Jean Hubble, VP of medical affairs, at Mitsubishi Tanabe's U.S. unit MT Pharma America Inc (MTPA), said.
ALS, whose cause is largely unknown, garnered international attention when New York Yankees player Lou Gehrig abruptly retired from baseball in 1939, after being diagnosed with the disease.
Reuters: FDA approves first ALS treatment in more than two decades
ALS is one of the worst diseases you can possibly get and the drug provides a substantive remedy toward slowing it significantly. In that respect, it's a medical research marvel.
The drug, known chemically as edaravone, has been sold by Japan-based Mitsubishi Tanabe in Japan and South Korea since 2015.
In the United States, the only other approved ALS medicine, generic riluzole, modestly slows the progression of the disease in some people.
After six months of treatment with edaravone on top of standard-of-care, data showed the intravenous drug reduced the rate of functional decline in patients by about a third, Dr Jean Hubble, VP of medical affairs, at Mitsubishi Tanabe's U.S. unit MT Pharma America Inc (MTPA), said.
ALS, whose cause is largely unknown, garnered international attention when New York Yankees player Lou Gehrig abruptly retired from baseball in 1939, after being diagnosed with the disease.
Reuters: FDA approves first ALS treatment in more than two decades
ALS is one of the worst diseases you can possibly get and the drug provides a substantive remedy toward slowing it significantly. In that respect, it's a medical research marvel.
However ...
If taken annually for 12 months or 13 cycles, according to the dosing and administration per the label, the cost before government discount would be $145,524, the company added.
- Reuters
The hope is shot all to hell before it even starts because there's no chance medical insurance will pay for it, with or without whatever Trump does to it. The situation has existed since the conception of this evil process of commercial insurance.
Unknown how people react to such a thing since some blow it off with, well, sucks to be you and waltz into the sunset. Others are likely to be furious. That's typically where it stalls and then nothing changes.
I've seen twice in the last five weeks, incidents in which insurance refused to pay for prescribed medication for dealing with live cancer and this is for someone they have been carrying on their roles for years. Ref: Blue Cross / Blue Shield
The insurance system is so broken no amount of second tier Washingtonian dibs and dabs will fix it. The People need to grab this bitch and deal with it rather than hanging on the words of the Holy Fathers in Washington who are actually only playing for a paycheck, often from the corporations they defend.
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