Sarepta Therapeutics lays off 500 employees amid FDA investigation, including 80 in Columbus

COLUMBUS, Ohio (WCMH) -- Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location.

According to a mass layoff notice filed with the state, biotech company Sarepta Therapeutics laid off 80 employees Friday in central Ohio. The move comes amid a federal investigation into fatal concerns in one of its gene therapy treatments, ELEVIDYS, which was developed at Nationwide Children's Hospital.

All affected Ohio employees worked at an office at 4201 Easton Commons. Columbus layoffs included managers, researchers, scientists and veterinary workers.

Sarepta Therapeutics is a global company that researches and develops genetic medication for rare diseases. ELEVIDYS was one of these treatments, used to help patients with Duschenne muscular dystrophy. On Friday, the same day as the layoffs, the FDA said it requested Sarepta voluntarily stop all shipments of ELEVIDYS, but claimed the company refused. The company later claimed it only heard of this request through news outlets, but confirmed it would not be complying with the request.

On June 24, the Food and Drug Administration announced it was investigating ELEVIDYS after receiving reports of two deaths and two cases of liver failure in adult men associated with the drug. In Friday's update, the FDA announced it has placed Sarepta Therapeutics' clinical trials for limb girdle muscular dystrophy on hold after a third death related to the drug.

The FDA said the three deaths all appear to stem from liver failure associated with ELEVIDYS treatments or relevant trials. The third death, a 51-year-old patient, occurred during clinical trials of an investigative new drug application for limb girdle muscular dystrophy that used similar gene technology. The other two deaths were both teenagers receiving ELEVIDYS treatments.

Sarepta said it will update its packaging to include a warning for acute liver injury or failure this week. The company announced in June that it is temporarily suspending ELEVIDYS shipments for non-ambulatory patients, those who cannot walk or move without assistance, but is continuing shipments for all other patients.

ELEVIDYS helps patients with Duchenne muscular dystrophy, a severe genetic disorder that causes patients to gradually lose strength in their muscles. The condition is life threatening and typically diagnosed in young children. People with Duchenne muscular dystrophy usually lose the ability to walk by age 12 and typically live into early adulthood, according to the Cleveland Clinic.

In an interview with Bloomberg this week, FDA Commissioner Marty Makary said the agency is also considering whether Sarepta Therapeutics' gene therapy should stay on the market.

Sarepta also has its Gene Therapy Center of Excellence in central Ohio, with locations in Dublin and the 3400 block of Seltzer Road. NBC4 reached out to Sarepta and Nationwide Children's Hospital for comment, but neither have responded.