Sarepta says Elevidys Citizen Petition misrepresents treatment-related deaths

Sarepta (SRPT), in a letter dated August 14 to the FDA, responded to the Citizen Petition related to Elevidys. The letter states in part: “The Petition misrepresents the number of treatment-related deaths associated with Elevidys, as well as the rate of hospitalization due to acute liver injury inpatients who have received Elevidys. To date, the deaths of two non-ambulatory Duchenne patients have been attributed to ALF following treatment with Elevidys and the overall rate of hospitalization due to ALI has remained consistent from clinical trials to the commercial setting at approximately 5-6%….The Petition refers repeatedly to data from the FAERS Public Dashboard to draw erroneous conclusions that do not reflect the limitations of the database that FDA itself acknowledges. As FDA expressly states, “the existence of adverse event reports for a drug or biologic in FAERS does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data is not an indicator of the safety profile of the drug or biologic..”