According to an analysis, the US FDA issued complete response letters (CRLs) to six novel drugs seeking first approval approvals during the first quarter of 2023. These CRLs highlight the stringent requirements for efficacy and safety data that the FDA demands before granting market access to new pharmaceuticals.<\/p>\n\n\n\n
Eli Lilly\u2019s Donanemab and Other Drugs Face Rejection<\/strong>
Among the products that received CRLs was Eli Lilly\u2019s Alzheimer’s disease therapy, donanemab. The FDA’s CRL, issued in January, noted that only a limited number of patients\u2014approximately 100\u2014who had received the drug treatment for at least 12 months in the trials used to support donanemab’s marketing were considered insufficient for full approval.<\/p>\n\n\n\n