ORLAND PARK, Ill. (WLS) — An infant in the Chicago area is confronting a rare illness and urgently requires a specific drug treatment to improve his life. This medication has now gained accelerated approval from the FDA.
The video in the player above is from a previous report.
The U.S. Food and Drug Administration announced on Friday that it will approve the Forzinity (elamipretide) injection, a treatment for the extremely rare disease known as Barth syndrome.
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The FDA had previously delayed its approval in part because the sample sizes were so low.
The pharmaceutical firm that manufactures the drug indicated that without this FDA approval, they might have had to close their operations. This could have been disastrous for one family in Orland Park, as discussed with ABC7 last month.
In his brief life, Adel Mohammed has experienced numerous challenges. He was just past one month old when he was taken to the hospital due to respiratory distress.
“We were just watching them attempt to intubate him,” said his mother, Nour Shaban. “During the intubation attempts, he went into cardiac arrest. We were simply stunned.”
Mohammed has been diagnosed with Barth syndrome, an extremely rare genetic disorder primarily affecting males, with only approximately 150 diagnosed cases across the country.
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
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