Batta Angelika, Kalra Bhupinder Singh, Khirasaria Raj
Department of Pharmacology, Maulana Azad Medical College, Saket, New Delhi, India.
Medical Affairs, Sanofi Genzyme India, Saket District Center, Saket, New Delhi, India.
J Family Med Prim Care. 2020 Jan 28;9(1):105-114. doi: 10.4103/jfmpc.jfmpc_578_19. eCollection 2020 Jan.
The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as potential candidate is one way to meet this important goal. Systematic investigation and comprehensive analysis of approved drugs could provide valuable insights into trends in the discovery and may contribute to further discovery of newer drugs systematically. Food and drug administration (FDA's) Center for Drug Evaluation and Research (CDER) every year summarizes novel drugs, some of which are truly innovative and help in advancing clinical care. This study was conducted to find a trend in drug approvals by FDA in the last 2 decades. Awareness of these new drugs amongst the primary care physicians is also crucial as they have been prescribing these agents in the past.
In this cross-sectional study, we collected, surveyed, and analyzed drugs approved by U.S. Food and Drug Administration (USFDA) from the year 2000 till 2017 identified from ClinicalTrials.gov and online database of FDA. Drugs approved every year were assessed for total number, class of drug, indication, and category of approval. Type of accelerated regulatory pathways and reasons for speedy approvals every year were also studied. Microsoft Office Excel 2007 was used for tabulation and analysis.
Total 209 were approved from 2000 to 2008. Out of these 9.09% were indicated for cardiovascular disorders and 12.91% for neurological disorders. Antibiotics (5.26%) and antivirals (5.74%) were least contributed, whereas anticancer drugs (11.96%) and biologics (7.17%) approval remained constant. Whereas, out of three hundred and two drugs approved during 2009--2017, 5.29% were for cardiovascular disorders, 9.93% for neurological disorders. Antibiotics (5.29%) and antivirals (5.96%) were least in number, whereas anticancer drugs (17.54%) and biologics (15.56%) approval took a steep rise in these years. Also, a wide variation in the number and category of approval was observed over a period of years. The use of fast track, accelerated approval, and priority review programs have also been steadily increasing since 2000.
There has been a steady rate of introduction of new drugs by CDER over the last two decades. Expedited approval of anticancer and biologics is seen as recent trend in drug development. Relatively, slow progress in approval of drugs for neurological disorders (depression, psychosis, multiple sclerosis, etc.) and lifestyle diseases like obesity, atherosclerosis, diabetes, etc., were seen. These findings reflect more emphasis being laid down in research for anticancer drugs and biologics.
新型药物的发现对于药物研发以及患者治疗至关重要。将可能具有预期效果的现有药物重新用作潜在候选药物是实现这一重要目标的一种方式。对已批准药物进行系统研究和全面分析，可以为发现趋势提供有价值的见解，并可能有助于系统地进一步发现更新的药物。美国食品药品监督管理局（FDA）药品评价和研究中心（CDER）每年都会总结新型药物，其中一些是真正具有创新性的，有助于推进临床护理。本研究旨在探寻FDA在过去20年中药物批准的趋势。初级保健医生对这些新药的了解也至关重要，因为他们过去一直在开这些药物。
在这项横断面研究中，我们收集、调查并分析了从ClinicalTrials.gov和FDA在线数据库中确定的2000年至2017年期间美国食品药品监督管理局（USFDA）批准的药物。对每年批准的药物进行总数、药物类别、适应症和批准类别评估。还研究了每年加速监管途径的类型和快速批准的原因。使用Microsoft Office Excel 2007进行制表和分析。
2000年至2008年共批准了209种药物。其中，9.09%用于心血管疾病，12.91%用于神经系统疾病。抗生素（5.26%）和抗病毒药物（5.74%）的占比最少，而抗癌药物（11.96%）和生物制品（7.17%）的批准数量保持稳定。然而，在2009年至2017年批准的302种药物中，5.29%用于心血管疾病，9.93%用于神经系统疾病。抗生素（5.29%）和抗病毒药物（5.96%）数量最少，而抗癌药物（17.54%）和生物制品（15.56%）的批准数量在这些年中急剧上升。此外，多年来批准的数量和类别存在很大差异。自2000年以来，快速通道、加速批准和优先审评程序的使用也在稳步增加。
在过去二十年中，CDER引入新药的速度一直稳定。抗癌药物和生物制品的加速批准被视为药物开发的最新趋势。相对而言，用于神经系统疾病（抑郁症、精神病、多发性硬化症等）以及肥胖、动脉粥样硬化、糖尿病等生活方式疾病的药物批准进展较为缓慢。这些发现反映出在抗癌药物和生物制品研究方面的重视程度更高。
