OMAHA, Neb. —

An Omaha mom is celebrating the FDA's approval of elamipretide for Barth syndrome.

The sign Jordan Karle held outside the White House in late August makes the alternative clear: "We implore the FDA to rescue our babies from certain death."

Karle's 1-year-old son Jaylin has Barth syndrome, a condition only 150 people in the U.S. are estimated to have.

A birth, Jaylin's heart was failing, Karle said. But after beginning elamipretide, Jaylin left the hospital after a month, she said.

Jaylin has had a nightly injection of elamipretide since then, Karle said, but the manufacturer, Stealth BioTherapeutics, would not have been able to support creation for much long without any FDA approval.

Elamipretide, which has a brand name of Forzinity, was granted accelerated approval o

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