-
Americas
-
Asia & Oceania
-
A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
-
Americas
-
Asia & Oceania
-
Europe
-
Middle East & Africa
-
Americas
-
Asia & Oceania
-
Europe
Europe
- Adriatic
- Belgium
- Bulgaria
- Czech Republic
- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
SOLUTIONS
-
Research & Development
-
Real World Evidence
-
Commercialization
-
Safety & Regulatory Compliance
-
Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
- Information Partner Services
- Financial Institutions
- Global Public Health
- Government
- Patient Associations
- Payers
- Providers
THERAPEUTIC AREAS
- Cardiovascular
- Cell and Gene Therapy
- Central Nervous System
- GI & Hepatology
- Infectious Diseases and Vaccines
- Oncology
- Pediatrics
- Rare Diseases
- View All
Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
LEARN MORE
Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Research & Development OverviewResearch & Development Quick Links
Real World Evidence. Real Confidence. Real Results.
Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
REAL WORLD EVIDENCE OVERVIEWReal World Evidence Quick Links
See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEWCommercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEWSafety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEWTechnology Quick Links
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSTHE IQVIA INSTITUTE
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTS
FEATURED INNOVATIONS
-
IQVIA Connected Intelligence™
-
IQVIA Healthcare-grade AI™
-
IQVIA AI Assistant
-
Human Data Science Cloud
-
IQVIA Innovation Hub
-
Decentralized Trials
-
Patient Experience Solutions with Apple devices
WHO WE ARE
- Our Story
- Our Impact
- Commitment to Public Health
- Code of Conduct
- Environmental Social Governance
- Privacy
- Executive Team
NEWS & RESOURCES
Unlock your potential to drive healthcare forward
By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
LEARN MORE
IQVIA AI is Healthcare-grade AI
Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
LEARN MORE
Meet the IQVIA AI Assistant
Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.
LEARN MORE
Your healthcare data deserves more than just a cloud.
The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
LEARN MORE
Innovations make an impact when bold ideas meet powerful partnerships
The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
LEARN MORE
Proven, faster DCT solutions
IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
LEARN MORE
IQVIA Patient Experience Solutions with Apple devices
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
LEARN MOREWORKING AT IQVIA
Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
LEARN MORELIFE AT IQVIA
Careers, culture and everything in between. Find out what’s going on right here, right now.
LEARN MORE
WE’RE HIRING
"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSBlog
2018 US FDA approval landscape - A new high!
Feb 08, 2019
2018 – a banner year for NME approvals by the US FDA
2018 has been a rolling year for approval activity by the US FDA - the agency’s Center for Drug Evaluation and Research (CDER) approved a record number of 59 novel medicines, known as new molecular entities (NMEs), which are processed through Type I NDA submission; this number is the highest in the history of US FDA approvals, surpassing a previous high of 53 NME approvals in 1996. For purpose of FDA review, the term NME applies to novel drugs approved under both New Drug Applications (NDAs) and Original Biologics License Applications (BLAs). The year 2018 peaks the chart of volume of NME approvals, as evident from Figure 1. From 2010 to 2018, the NME approvals by the US FDA averaged to 37 per year.
A watershed year for drug innovation
2018 proved to be a significant year for drug innovation as the NME approvals in the USA were outstanding not just for quantity but also for quality – there are many striking examples of NMEs that bagged the ‘first-ever’ or ‘first-and-only’ therapy for a particular indication, or were ‘first-in-class’ with a unique mechanism of action, or represented a newer treatment option for a niche group of patients for the first time in decades. The record high of approvals can be attributed to utilization of the expedited review program benefits offered by the FDA, thereby ensuring speedy approval of drugs. Of the NMEs approved in 2018, three-quarters (75%) were approved under Priority Review, four in total were approved under Accelerated Assessment, about one out of four (24%) received Breakthrough Therapy designation and about four out of ten (41%) received Fast Track designation.
Impact of approvals
As depicted in Figure 2, of the NMEs approved in 2018, about a third (20; 34%) were identified as first-in-class drugs, over half (34; 58%) were approved to treat a rare disease and 7 out of 10 (42; 71%) approved drugs received first ever worldwide approval in the USA.
Conclusion
This year the US FDA has granted NME approvals at a sweltering rate bringing many novel therapies from bench to bedside. The variety in NME approvals will benefit various patients suffering from ailments ranging from rare disorders to common diseases. A trend of rise in development and approval of orphan drugs is evident – for the first time ever the majority of NMEs approved in 2018 are for the treatment of rare diseases. The US FDA is working at a swifter pace in reviewing regulatory filings and approving more drugs than the EMA. In 2018, 7 out of 10 drugs approved by the US FDA received approval first in the USA before anywhere else in the world. Also, the USA is primarily the first target market for companies to develop and file for approval of novel drugs compared with rest of the world. Speedy approvals can grant access to newer treatment options for patients. However, only the coming years can testify whether the impact of increased approvals of novel drugs will translate to safer, clinical- and cost-effective therapies that demonstrate evidence-based benefits in the real-world.
Register to the INNsight Newsletter for regular patent, pipeline and conference updates.