FDA Maintains Record-Breaking Approval Pace Despite Organizational Upheaval, Highlighting Three Breakthrough Therapies
核心洞察
The FDA has approved 84 drugs in 2025 so far, marking the second-highest total for this period despite major organizational changes including 3,500 staff layoffs.
Gilead's Yeztugo (搜索) represents a potential game-changer for HIV (搜索) prevention with 100% efficacy in phase 3 trials and twice-yearly dosing, though priced at $28,218 annually.
Daiichi Sankyo's ADC portfolio expansion continues with Datroway's lung cancer (搜索) approval, while GSK's Blujepa (搜索) becomes the first new urinary tract infection antibiotic in three decades.
The FDA has maintained a near record-breaking pace of drug approvals in 2025, authorizing 84 treatments through May despite significant organizational disruption that included layoffs of 3,500 staff members earlier this year. The total represents the second-highest approval count for this period, trailing only 2024's record-setting performance, according to Clarivate data.
The agency's productivity has continued even as it navigates major upheaval within the Department of Health and Human Services. A reorganization and workforce reduction effort triggered widespread staffing changes, with some employees returning while others departed as new leadership took positions. Most recently, Jacqueline Corrigan-Curay, the acting head of the Center for Drug Evaluation and Research (CDER), announced her retirement next month.
Among the 84 approvals, 16 represent novel drugs spanning therapeutic areas from oncology to rare diseases and pain management. While some companies including KalVista Pharmaceuticals and Stealth Biotherapeutics reported delays in their PDUFA dates, the FDA maintains that application reviews are proceeding as expected and has implemented streamlining measures including a pilot AI program.
Gilead's HIV Prevention Breakthrough
Gilead Sciences secured FDA approval for Yeztugo (搜索) (lenacapavir), a reformulated pre-exposure prophylaxis treatment that achieved 100% protection against HIV (搜索) in a phase 3 study involving more than 2,000 women. The twice-yearly injection represents a significant advancement over existing PrEP regimens that require daily oral doses or injections every few months.
Despite research suggesting the treatment could be manufactured for $25 per patient annually, Gilead set the U.S. list price at $28,218 per year, comparable to other PrEP treatments. The company stated it is collaborating with payers to "ensure broad coverage" and has established programs to reduce patient out-of-pocket costs.
The approval comes as global HIV (搜索) prevention efforts face potential challenges. With approximately 1.2 million Americans infected with HIV and the disease disproportionately affecting sub-Saharan Africa, the World Health Organization's goal to "end HIV/AIDS" by 2030 may be complicated by reduced U.S. funding for foreign aid and healthcare, which has already impacted HIV clinical work overseas.
Gilead has arranged agreements with six generic drug manufacturers to produce and distribute lenacapavir royalty-free in 120 low- and middle-income countries, while pursuing regulatory approvals in additional markets to expand global access.
Daiichi Sankyo's ADC Expansion
Daiichi Sankyo continues building its antibody-drug conjugate portfolio with Datroway's recent accelerated approval for lung cancer (搜索) patients, adding to the drug's January authorization for metastatic HR-positive, HER2 (搜索)-negative breast cancer (搜索). The AstraZeneca-partnered ADC joins seven existing approvals for the company's blockbuster Enhertu.
"This first approval of Datroway in lung cancer (搜索) provides a much-needed option to patients whose disease has become resistant to past treatments, regardless of the driving mutation," said Dave Fredrickson, executive vice president of AstraZeneca's oncology hematology business unit.
The approval supports Daiichi Sankyo's ambitious goal to bring five ADCs to market across 30 different indications by 2030. While Enhertu generated approximately $3.8 billion in sales last year, Datroway is projected to reach $33 million in 2025 sales. However, AstraZeneca projects the drug will achieve blockbuster status, having invested up to $1 billion upfront in a 2020 development deal and estimating peak sales could reach $5 billion.
First-in-Class Antibiotic Innovation
GSK received FDA approval for Blujepa (搜索), addressing a critical gap in antibiotic innovation for urinary tract infections (搜索). The triazaacenaphthylene antibiotic represents the first new treatment for this indication in approximately three decades and employs a novel mechanism of action by inhibiting bacterial DNA replication through a distinct binding site.
The approval is particularly significant given the scarcity of innovative antibiotics. According to WHO data, only two of the 13 antibiotics approved between mid-2017 and 2023 belonged to new drug classes, highlighting the rarity of Blujepa (搜索)'s first-in-class status.
The authorization supports GSK's objective to launch five new products this year as the company diversifies beyond its traditional vaccine leadership. Facing potential challenges in the immunization market under new FDA leadership and declining demand for its RSV shot Arexvy, GSK is leveraging its expanded portfolio in oncology and respiratory disease. The company estimates that Blujepa (搜索) and two other general medicine drugs will achieve combined peak sales of approximately $2.6 billion.