Onglyza Case Study: Navigating New Safety Concerns To Win Market Approval In Diabetes

STUDY OVERVIEW

This case study reviews the opportunities and challenges faced by Bristol-Myers Squibb and AstraZeneca at the tail end of the development of Onglyza (saxagliptin), a treatment for type 2 diabetes. A second generation DPP-4 inhibitor, Onglyza was poised to follow on the success of Merck's Januvia when development partners BMS and AZ had to deal with a changing regulatory environment relative to safety. After its pivotal clinical trials had been launched, the FDA issued new, more stringent requirements for assessing safety of diabetes therapies, in particular for cardiovascular risk. The saxagliptin development team had to respond to these requirements as it tried to gain approval in this new regulatory climate. This study also reviews FDA's new requirements for assessing the safety of diabetes therapies in clinical testing. Executives and managers can use this research to gain insights into methods for navigating new safety concerns to win market approval in diabetes.

KEY TOPICS

• Market Entry for Second Generation DPP-4 Inhibitor
• Initial Product Profile Promised a Clear Path to Market
• Navigating a Changing Regulatory Environment
• Responding to New FDA Guidance for Developing Anti-Diabetes Products

• Long Term Cardiovascular Safety Trials: FDA guidance clearly signaled that future clinical trials should engage sicker patients to assess whether they are at greater risk of cardiovascular events. This will likely require longer clinical trials. FDA guidance indicated 2-4 years. This lays down a critical market entry factor for future anti-diabetic therapies.

• Risk Assessment & Post-Marketing Trials: When the Onglyza (saxagliptin) team finally met with the FDA in 2009, the Endocrinologic and Metabolic Drugs Advisory Committee articulated various “Voting Questions” that reflected the essence of FDA safety concerns. Moreover, these questions reflect the hurdles that future anti-diabetes therapies will need to address.

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