With the introduction of a new drug that may one day help treat people with Parkinson’s disease, a few of the companies behind it are wondering whether they will be able to use the new drug on humans.
On Monday, Nov. 20, the FDA granted the first-ever FDA approval for the drug, the BRAV-11, for use in people with a type of brain injury known as focal neurodegeneration.
This is a devastating condition that causes loss of brain cells and nerve cells that control movement and other functions.
It is commonly referred to as “brain death” and is often diagnosed in people over 65.
Dr. Stephen S. Cohen, president of the American Academy of Neurology, said the drug is likely to be used for a subset of patients, such as those with Parkinson disease.
He said there are some preliminary indications that the BRAv-11 may work as a treatment for patients who have suffered severe strokes or other forms of stroke.
“It’s a really exciting discovery, because if it works as a tool for a small subset of people with stroke, then there are other populations that might benefit from it as well,” he said.
“If it works for some of those patients, it could be a big game changer.
It would give hope to patients suffering from other forms [of brain injury].”
The BRAv is being developed by scientists at the University of Michigan in Ann Arbor, Michigan.
A company called Translational Neuroscience Inc., based in San Diego, California, is developing the drug as part of a joint effort between the National Institutes of Health and the U.S. Food and Drug Administration.
The BRAV is approved to treat patients with focal neuroprogression, a condition that occurs in 1 in 5 people who develop a brain injury.
A person with focal neurologic disorder is most likely to have a severe stroke, a stroke that causes significant damage to the brain.
The condition is extremely rare.
It has been estimated that the drug could be used in 20 million patients with severe or moderate to severe Parkinson’s, and a potential 5 million more patients.
But the drug does not yet have FDA approval to treat people suffering from severe or chronic brain injury or stroke, so there is a very good chance that it won’t work in those patients.
“We are really interested in this drug for people with mild or moderate disease.
We are interested in a subset, but it’s going to take a few years before we see this drug in people that suffer from mild or chronic disease,” Dr. Cohen said.
While the drug has not yet been approved by the FDA for use for stroke patients, the researchers say that they are hopeful that it will one day.
“Our goal is to move quickly, because we have very good data from a study that was published in a journal a few months ago.
And so it is our hope that this is a drug that will have great success in people who suffer from severe and moderate brain injury and stroke,” Dr Cohen said, adding that he is excited about what the company is building.
The Drug Development and Licensing Authority of Canada, which has oversight of BRAv, is planning to issue an application for approval of the drug for patients with moderate to mild disease, but Dr. Sheshbhav said it may take several years to see this first drug in the United States.
Dr Sheshebhav and his team are hoping to have their BRAv drug approved in the first half of 2018, after they have exhausted all the other options.
“This is the first time we have ever seen this drug approved.
We’re extremely optimistic, but we are also extremely cautious,” he added.”
What is exciting is that we are working on this in partnership with a group of companies that have a very strong history of innovation, and that’s why we are so optimistic.”
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