Updated report analyzing approval rates at FDA published

Sagient Research Systems, a leading publisher of independent research for the financial services, institutional investment and corporate intelligence communities, recently published an updated report analyzing approval rates at the U.S Food and Drug Administration (FDA). According to its research service, BioMedTracker, the rate of drugs that were approved by the FDA in 2008 and 2009 has remained close to the historical low seen in 2007. The report also examined the role FDAAA legislation, enacted in 2007, has played in the FDA not reaching its PDUFA goals. In addition, the report analyzed the impact advisory panels have on FDA decisions, approval timelines for drugs receiving Risk Evaluation and Mitigation Strategy (REMS) programs, and stock price movements around PDUFA dates. The report mentioned several high profile FDA decisions expected in 2010, including Dendreon's Provenge for prostate cancer, InterMune's Esbriet for idiopathic pulmonary fibrosis (IPF), and Vivus' Qnexa for obesity.

BioMedTracker is an independent research service that offers proprietary clinical assessments and patient-based revenue forecasts of developmental drugs within a comprehensive and intuitive drug information database. Clients from the pharmaceutical, biotech, and investment industries rely on BioMedTracker for its insight on the likelihood of approval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape of every important disease and indication. CatalystTracker is the most efficient method to track upcoming volatility events for public companies. Catalysts are constantly updated by Sagient's in-house analyst team and presented to clients online in an easy to use, searchable, and customizable format. 

Commenting on the report of FDA Approval Rates, Michael Hay, Senior Analyst and Product Manager for BioMedTracker said, "Despite an increase in the overall number of drugs being approved since the low seen in 2007, the overall rate of approvals has remained depressed as compared to 2006. Increased responsibilities and authorities granted to the FDA under FDAAA have created new dynamics to the approval process, such as the need for REMS programs. This has led to extended approval timelines and it is important for the industry to analyze and implement all the elements needed for approval early in the drug development process." Hay continued, "In 2009 we saw striking Phase III data from companies such as Dendreon and Vivus. In 2010 that data will lead to some exciting FDA decisions. We eagerly await what is again sure to be a thrilling and volatile year for companies navigating the FDA."