Complete response letters (CRLs) for novel products in 2018 didn't prevent the US FDA's year-end novel approval count from reaching a historic high, but a lack of evidence of efficacy appeared to be the chief culprit for new molecular entities (NMEs) and new biological entities (NBEs) being derailed.
2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections
US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.
More from Complete Response Letters
• By
While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
• By
Acting Commissioner Sara Brenner rejected the company’s request for a hearing, saying the lack of an adequate and well-controlled trial showing tasimelteon's effectiveness in treating sleep-onset insomnia is “fatal to the application.”
• By
Prospects are promising for many of the 16 novel candidates that received complete response letters in 2024 after half of the 2023 CRL class was approved the following year.
• By
Vanda’s fight against a complete response letter for its gastroparesis drug results in a notice of opportunity for hearing on a formal FDA proposal to refuse to approve the NDA.
More from Product Reviews
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.