Na terça-feira, o Sarepta Therapeutics disse que a primeira fatalidade registrada associada à sua terapia genética para distrofia muscular de Duchenne, Elevidys, ocorreu em um garoto de 16 anos.
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Teen Who Received Elevidys Infusion Dies
Nos últimos 20 anos, vários procedimentos de terapia genética foram conhecidos por causar insuficiência hepática, que foi o que aconteceu com o jovem. [Leia mais: Perguntas frequentes sobre Elevidys usado para distrofia muscular de Duchenne]
The death “represents a severity of acute liver injury not previously reported for Elevidys,” Sarepta noted. The patient had also tested positive for cytomegalovirus (CMV) infection, which can damage the liver and is “a possible contributing factor” to the death, according to the announcement. Sarepta expressed “profound” sadness over the death. [O que é infecção por citomegalovírus (CMV)?]
Sarepta Shares Drop 28%
Sarepta has reported the death to the relevant health authorities and will update Elevidys’ label to “appropriately represent this event,” the biotech noted in its Tuesday release. The company’s stock plunged around 28% as the markets opened on Tuesday to $73.01, down from $101.35 at the previous market close.
Saber mais: Revisão de ensaios clínicos da terapia genética Elevidys: o Elevidys vale o custo?
In Which Country and In Which Hospital Did This Sad Incident Occur?
It was reported by Sarepta that the young DMD patient who died was a US citizen and the incident occurred in the US. [Read more: Community Letter]
If sufficient and satisfactory information comes from Sarepta, we will notify all DMD communities that we will make a special news on this subject.
