背景:多年来,COVID-19造成的破坏继续给制药业带来过多的挑战。整整一年,有人质疑COVID-19是否会对新药批准产生负面影响。然而,这些问题的答案是“大不”。
方法:我们建议对大约100种药物进行汇编和分析,包括小型新分子实体(NME),由美国食品和药物管理局批准,适用于2020年和2021年。新型药物的发现对于药物研究和开发以及患者护理至关重要。实现这一关键目标的唯一可能方法是重新调整当前可能具有预期效果的药物作为可能的候选药物。新药和生物制品的获得通常意味着患者的新治疗选择和医疗保健的进步。结果:大约40%的药物被批准用于各种类型的癌症。关注的其他主要治疗领域是神经学产品(约17%),传染病(13-15%),和心血管疾病(7-8%)。各种新产品被批准用于罕见疾病(58-60%)。这项研究旨在发现过去二十年来FDA药物批准的模式。
结论:这些数据表明,抗癌药物和生物制剂在研究中受到越来越多的关注。随着越来越多的生物衍生药物的生产,价格可能会上涨得更高。FDA应该采用创新技术,以刺激行业加强新型化合物或药物的研究和开发,这些化合物或药物可以比现有的化合物或药物有相当大的改进。简单地说,FDA必须更新我们的整体监管方法,以便有效地开发可用的技术类型。现代化医疗产品审查计划是其中的一部分。这些举措是医疗创新准入计划的一部分。
BACKGROUND: Throughout the years, the disruption caused by COVID-19 continues to pose an excess of challenges for the pharmaceutical industry. Throughout the entire year, questions were raised that does COVID-19 have a negative impact on new drug approvals. However, the answer to those questions was a \'big no\'.
METHODS: We propose a compilation and analysis of around 100 medications, including small new molecular entities (NMEs), approved by the US Food and Drug Administration for the years 2020 and 2021. Novel drug discovery is crucial for pharmaceutical research and development as well as patient care. The only possible way to achieve this crucial goal is to repurpose current medications that may have anticipated effects as possible candidates. The availability of new drugs and biological products often means new treatment options for patients and advances in health care.
RESULTS: Around 40% of the drugs were approved for various types of cancers. Other major therapeutic areas that were focused on were neurological products (around 17%), infectious diseases (13-15%), and cardiovascular disorders (7-8%). Various new products were approved for rare diseases (58-60%). This study aimed to discover a pattern in FDA medicine approvals during the last two decades.
CONCLUSIONS: This data shows that anticancer medicines and biologics are receiving increased attention in research. With a bigger number of biologically derived medications being produced, the price could rise much higher. FDA should embrace innovative techniques that will stimulate the industry to enhance research and development of novel compounds or medications that can deliver considerable improvements over existing ones. To put it briefly, FDA had to update our approach to regulation as a whole in order to effectively develop the types of technologies that are becoming available. Modernizing medical product review programmes is a part of this. These initiatives are part of the Medical Innovation Access Plan.