For the first time in two decades within the USA, a new drug has been approved that is supposed to increase patients' chances to slow down the disease's progression and functional deterioration. Motor nerves (green) found in the spinal cord project out long, thin axons to the periphery, where they contact muscles (black background), forming specialised connections or synapses called neuromuscular junctions (NMJs, red).
"After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States", Eric Bastings, the deputy director of the FDA's neurology products division, said in a statement.
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 MTPC's US unit MT Pharma America (MTPA), said. The only other drug specifically for the treatment of ALS is riluzole, which was approved for use in the United States in 1995.
The CDC estimates that 12,000 to 15,000 Americans have ALS.
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The only other FDA-approved ALS treatment in the USA, generic riluzole, has been proven to modestly slow the progression of the disease in some patients, but data showed the Radicava reduced the rate of functional decline in ALS patients by about a third, said VP of medical affairs, at MTPC's US unit MT Pharma America (MTPA), Dr Jean Hubble. The drug Radicava has been developed in Japan.
The company estimated that Radicava will be available in the United States this August.
The non-profit ALS Association applauded the FDA's decision. Voluntary muscles produce movements such as chewing, walking, breathing and talking. It said the going price for Radicava is $11,000 per dosage cycle, or about $146,000 a year.
Edaravone is given as an intravenous infusion, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period.
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It can have severe side effects.
Radicava would cost $1,086 per infusion, Mitsubishi Tanabe Pharma said on Friday. "The drug also has caused hives, swelling, shortness of breath and allergic reactions".
An orphan drug is one that is unlikely to have many buyers, so the FDA speeds approval. This treatment repeats with dosing 10 out of 14 days and another 14-day drug-free period, according to the FDA.
The most common adverse reactions reported by clinical trial participants receiving edaravone were bruising (contusion) and gait disturbance.
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