(MENAFN) After receiving Zolgensma gene therapy, frequently referred to as the most expensive medication in the world, two children died of acute liver failure, the drug's maker Novartis reported on Thursday.
As stated by the Swiss pharmaceutical company, acute liver failure is a "known adverse event" of the medication used to treat patients with spinal muscular atrophy (SMA), but these are the first fatal cases brought on by this complication. As per Novartis, the patients had received corticosteroids to prevent severe liver damage.
The deaths happened in Russia and Kazakhstan. It also said that it had updated medical personnel as well as informed health authorities in the markets where the drug is sold. Each patient receiving Zolgensma costs about $2 million.
“Pending health authority review and approval, the Zolgensma label will be updated to inform prescribers that fatal acute liver failure has been reported,” the manufacturer stated.
Even though the fatal cases are "important safety information," Novartis emphasized that they are not regarded as "a new safety signal" because they "firmly believe in the overall favorable risk/benefit profile of Zolgensma." More than 2,300 patients have already received treatment with the drug, according to the pharmaceutical company, "across clinical trials, managed access programs, and in the commercial setting."
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