ANVISA SUSPENDS SALE OF REMEDY OF UP TO R $ 20 million

The pharmacist also says that there were no deaths related to the treatment among the approximately 760 (who can walk) patients who have already received the therapy and that, based on current data, the benefit-risk follows positive. He also says dialogue with Anvisa and global authorities.

Anvisa, in turn, points out that all deaths were linked to nominations not authorized here.

In the country, the medicine was authorized in December 2024, exceptionally, exclusively for pediatric patients who can walk, aged 4 to 7 years, with a mutation confirmed in the DMD gene.

Still, the suspension was taken “prudently and preventively”, while new security analyzes are conducted in partnership with international regulators.

According to the FDA statement on Friday (25/7), the latest investigation involves the death of an eight-year-old child on June 7. The agency requested the voluntary suspension of product distribution while investigating if there are problems with product security. There were two other deaths – one adult and a child.

According to FDA, the three reports of acute liver failure with death involving genetic therapies of Sarepta based on AAVRH74 vector are in two non -gun -treated boys and treated with elevidys and an adult with waist muscular distrophy that participated in clinical trial with experimental therapy.