July 28 (Reuters) -
Sarepta Therapeutics ( SRPT ) said on Monday it will resume
shipping of its gene therapy Elevidys to patients with a rare
muscular disorder who can walk, after the FDA recommended the
removal of a voluntary hold that was placed on the therapy.
However, the use of the gene therapy remains on hold for
Duchenne Muscular Dystrophy patients who cannot walk, the FDA
said, adding that it is continuing to work with the company
while investigating the death of two patients.
The FDA's recommendation for ambulatory patients - those
who can walk - followed a probe that showed the death of an
eight-year-old boy in Brazil, was unrelated to the gene therapy,
the agency said.
Roche, which has partnered with Sarepta for
commercialization outside the U.S., had previously said the
patient's death was not related to the therapy, according to the
reporting physician's assessment.
Sarepta is also facing intense scrutiny following the death
of two non-ambulatory teenage boys associated with Elevidys, as
well as a 51-year-old man who had received its experimental gene
therapy SRP-9004.