As FDA Delays Approval, Mom Fears Son with Rare Disorder Could Lose Access to Drug She Says Is Saving His Life

As FDA delays approval, Mom fears son with rare disorder could lose access to drug she says is saving his life | News Channel 3-12

By Aaron Hegarty Click here for updates on this story     OMAHA, Nebraska (KETV) — An Omaha mom says Food and Drug Administration approval of a drug intended to address her son’s rare condition can’t wait. Jordan Karle’s 1-year-old son Jaylen experienced heart failure from birth because of Barth syndrome, a deadly, rare condition estimated to affect around 150 people in the U.S. The FDA denied approval of the drug, elamipretide, last week, but g…

As FDA delays approval, Mom fears son with rare disorder could lose access to drug she says is saving his life

Click here for updates on this story

As FDA delays approval, Omaha mom fears son could lose access to experimental drug

Last week, the FDA denied approval of a drug to treat a rare and deadly genetic disorder affecting the heart, but gave a pathway to approval.