The life-saving injection for an infant with cerebral palsy could soon be on the horizon, but only if it’s made available to the world through a new drug.
Dr. David Dao, the chief medical officer for the U.S. Food and Drug Administration, is launching a clinical trial to test a drug called JZP-003 in children.
The drug will likely be the first of its kind in the U-19 and U-20 world.
The FDA is already looking into the drug, and Dao told a news conference Tuesday that JZL-001 could be approved as soon as next year.
But the drug could take years to reach a market, and it will have to be tested on a large enough number of patients to make any real dent in the global number of people with cerebral paralysed, said Dr. Scott Lutz, a pediatric neurologist at Children’s Hospital of Philadelphia.
The new drug is a different kind of treatment, one that has been around for decades, and has been tested in millions of children worldwide.
Dao said the drug would be different from the standard drug used to treat cerebral palsies in that it would be an infusion of blood, rather than a shot, and would not require any special training to administer.
Dao said JZM-003 will target children who have low IQs, are developing speech or are suffering from behavioral issues.
It has also been used to manage the growth of neural stem cells, the precursors to neurons.
Dr Lutz said the new drug would target those who are more than six months old.
It’s not clear how many children would be targeted in the trial, but Lutz predicted that the drug’s effectiveness in that age group would be significantly higher than the average of all other children.
“I think this is a really important thing to do, and we need to look at how this drug can be used in kids,” Lutz told Reuters Health.
A spokesperson for the FDA said that it is not yet clear how long the drug will take to be approved for adults, and added that there are no current plans to move forward on that.
