FDA Fast-Tracks Approval of Treatment for Orland Park Infant with Rare Barth Syndrome

ORLAND PARK, Ill. (WLS) — A baby in the Chicago area is battling a rare disease and desperately needs a drug treatment for a better life. The drug has now been granted accelerated approval by the FDA.

The video in the player above is from a previous report.

The U.S. Food and Drug Administration announced Friday it will approve the Forzinity (elamipretide) injection that is currently used to treat an ultra-rare disease called Barth syndrome.

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The FDA had previously delayed its approval in part because the sample sizes were so low.

The pharmaceutical company that produces the drug said it could have gone out of business without the FDA approval. For one family in Orland Park, that would have spelled disaster. They spoke with ABC7 last month.

In his short life, Adel Mohammed has already been through so much. He was not much more than a month old when he was rushed to the hospital in respiratory distress.

“We’re just watching them trying to intubate him,” his mother Nour Shaban said. “While they are trying to intubate him, he went into cardiac arrest. We were just in shock.”

Mohammed was diagnosed with Barth syndrome, an ultra-rare genetic disease that affects mostly males. There are only about 150 cases diagnosed nationwide.

Mohammed has been getting daily injections of elamipretide for months now.

“Even his pediatrician says he’s a miracle baby,” Shaban said. “He’s able to sit up on his own. Lift his head up on his own. He’s showing things he should be delayed with.”

According to the Barth Syndrome Foundation, without treatment, sufferers will exhibit muscle weakness, heart failure and delayed growth. Most early deaths happen in infancy.

After ABC7’s initial report, Stealth BioTherapeutics announced the FDA agreed to fast-track the process.

“While the FDA considers the resubmission a complete, class 2 response with a six-month user fee goal date of February 15, 2026, the agency has advised the Company that its planned goal date is September 26, 2025,” the press release said.

On Friday, the FDA made the official announcement on the drug’s accelerated approval