The Food and Drug Administration approved 55 drugs this year, making it the second-best yearly harvest since 2022. Monoclonal antibodies (mAbs) led the way with 12 approvals, including first-of-its-kind treatments for psoriasis, respiratory syncytial virus and myasthenia gravis. In contrast, no antibody-drug conjugates (ADCs) were accepted this year, a marked change from previous years when the FDA has approved up to 14 of these drugs.
The FDA gave AstraZeneca’s PD-L1 inhibitor Imfinzi an expanded label on Wednesday to include use in patients with limited-stage small cell lung cancer who haven’t progressed after chemotherapy and radiation. The company’s supplemental New Drug Application, which included readouts from the Phase III ADRIATIC trial, showed that treatment with the drug significantly reduced the risk of death and progression-free survival versus placebo.
BridgeBio’s tafamidis received FDA approval on Thursday to be used in combination with other therapies to treat transthyretin (TTR) disease. The TTR stabilizer’s broad label specifies that it reduces the risk of death and hospitalization in patients with advanced transthyretin disease, Evaluate reports. TTR disease is a rare, progressive and life-threatening condition.
The FDA’s recent round of layoffs and earlier voluntary buyouts have reportedly affected the number of staff members who review new medicines, STATreports. As a result, reviewers have been struggling to keep up with their workloads and have missed deadlines in some high-profile cases. In a bid to cut review times and improve efficiency, the agency is considering using artificial intelligence to help streamline the final stages of its decision-making process.
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