FDA grants CRL for Bristol-Myers, AstraZeneca diabetes drug NDA
Bristol-Myers Squibb and AstraZeneca have received complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the new drug application (NDA) for Dapagliflozin as a treatment for type 2 diabetes in adults.
Dapagliflozin, an inhibitor of SGLT2, is being investigated to assess the safety and efficacy in improving glycemic control in adults with type 2 diabetes, for use as a monotherapy and in combination with other anti-diabetic agents.
The complete response letter requests additional clinical data including data from ongoing studies and from new clinical trials to provide a better assessment of the benefit-risk profile for Dapagliflozin.
As part of the application procedures, both the companies will work closely with the FDA to determine the appropriate next steps for the Dapagliflozin application and discuss with health authorities in Europe and other countries.
The benefit-risk profile of the investigational medicine is evaluated from clinical development programs that included more than 8,000 adult patients with type 2 diabetes.
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes.
Related Insight
Suppliers Directory
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
Intelligence
GBI Research, the leading business intelligence provider, has released its latest report, “Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential” that provides key data, information and analysis of the major trends and issues affecting the global nano-enabled drug delivery market. The report provides a comprehensive insight into the current and future application of nanotechnology in the drug delivery systems. It also provides an insight into the key drivers and barriers for the market growth. The report also provides a detailed analysis of the trends and its effects on the nano-enabled drug delivery market. The report also talks about the key regulations that affect the nanotechnology research and development and issues related to its use in pharmaceutical market. The report also details some case study of the latest technology being exploited in pharmaceutical industry. The report also provides detailed analysis of major deals that have happened in the nano-enabled drug delivery market landscape. At the end, the report looks into the future players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. The nano-enabled drug delivery market has been a high growth market and expected to grow at a faster rate in the near future. According to a study conducted by Willi Paul, and Chandra P. Sharma, the nano-enabled drug delivery market was $1.7 billion in 2009 and expected to reach over $4.8 billion in 2012. The market will witness increased competition, high investment from venture capitalist and government. The M&A and Licensing landscape will see significant changes in the coming future. This is because market is expected to become more lucrative in coming future. The major drivers for the market growth are Increasing acceptance of nano-enabled drugs, and a strong pipeline portfolio. The increasing governmental funding and R&D interest will strengthen the market in future. However, lack of consistent policy on technology transfer, poor R&D facility, and tight audit control and lack of centralized system will restrain the market growth. The nano-enabled drug delivery market has strong pipeline. The pipeline is primarily dominated by molecules in early stage of development. This suggests that the there is high level of R&D investment. This will support the future market and will fuel the licensing activity. Reports Buy online from $3500
Comments may be moderated for spam, obscenities or defamation.