The U.S. Food and Drug Administration gave the green light to accelerate the approval of Qalsody, a drug treating a specific form of the neurological disease amyotrophic lateral sclerosis, the agency said Tuesday.

Amyotrophic lateral sclerosis, more commonly called ALS, is a rare, incurable disease that affects motor neurons in the brain, making the individual lose ability to move over time, according to the National Institute of Neurological Disorders and Stroke.

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The accelerated approval process is used by the FDA to allow early approval of drugs “that fill an unmet medical need,” according to the FDA.

Biogen, the pharmaceutical company behind Qalsody, said the drug treats ALS cases that are associated with a toxic protein called superoxide dismutase 1 (SOD1), which damages nerve cells.

Reuters said about 16,000 to 32,000 people in the U.S. have ALS, and 2% of those cases are associated with SOD1.

The New York Times said the expedited approval is based on evidence that the drug can significantly reduce levels of the toxic protein.

Testing results

Though Biogen said the results of reducing the protein would likely help patients, “the drug, in a clinical trial, did not significantly slow the progression of the disease, as measured by patients’ ability to speak, swallow and perform other activities of daily living,” The New York Times said.

Despite this news, The New York Times said the vote by the FDA to grant conditional approval of Qalsody was unanimous.

Colin Quinn, a neurologist at Penn Medicine, told Reuters the effect of the drug is “large enough that you can see that (the) disease is fundamentally different than it would have been if patients weren’t on the drug.”

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Looking forward

In order to remain on the market, Biogen will need to provide more evidence to the FDA showing Qalsody’s benefit, Reuters said.

CNBC said, “If a subsequent trial confirms those benefits, the FDA can grant traditional approval for the drug.”

Reuters said Biogens estimates pricing the drug at $50 out-of-pocket per month for ALS patients, depending on each patient's insurance plan.

According to the FDA statement, Qalsody is administered as a spinal injection, with three initial doses every two weeks, followed by maintenance doses every four weeks.