Diabetes Drugs Undergo Renewed Scrutiny from U.S. FDA

FDA Committee Meets

The U.S. FDA is organising a two-day summit, the Endocrinologic and Metabolic Drugs Advisory Committee Meeting, with agency officials and independent stakeholders including medical experts set to attend. The agenda for the meeting is to discuss the inclusion of stringent benchmarking clinical assessment norms on the cardiovascular effects of drugs and biologics used in the treatment of Type 2 diabetes. The agency has indicated that the discussion will also look at the impacts on lifespan. The agenda was triggered in part by the recent post-marketing episodes relating to Schering-Plough's (U.S.) cholesterol drug Vytorin on efficacy issues, and U.K. firm GlaxoSmithKline's (GSK) diabetes drug Avandia, wherein issues of drug's adverse events concerns have sparked patient- and consumer-led litigations against each respective firm. Additionally, heart disease and associated cardiovascular risks are understood to be leading death causes of diabetics.

The issue of appointing "surrogate endpoints" to ascertain cardiotoxicity is likely to affect drug development in the segment, notes the Wall Street Journal. Furthermore, potential changes in clinical trial research methods for new drug approvals could be made if those discussed by the FDA advisory panel committee are implemented. The source adds that existing diabetes drug majors, such as U.K. firm GlaxoSmithKline (GSK) and Takeda (Japan), are expected to be affected if the post-marketing clinical studies framework for diabetes drugs is endorsed. The United States is one of the largest contributors to the US$24.7-billion global diabetes drug market.

Outlook and Implications

The FDA's decision to engage in a debate on diabetes drugs' linkage to cardiovascular effects is an indication of further scrutiny of post- and pre-approved drugs in the therapeutic area. The possibility of a potential expansion into other therapeutic segments such as oncology is one of the main concerns of the drug industry. The direct impact, however, lies with the cost of clinical trials, which will increase if the FDA insists on looking at the cardiovascular effects of the diabetes drugs. There is also concern over whether the surrogate endpoints will be achievable given that no diabetes drug has so far been able to demonstrate beneficial cardiac effects, as noted by the FDA, reports the Wall Street Journal. The drug industry is thus likely to oppose the implementation of further norms, noting that this will affect new drug development and approvals in the segment. The industry is already affected by increasing safety- and efficacy-related scrutiny from the regulatory agency and will point out that these measures are likely to hit industry interest in the therapeutic area. However, the impact is unlikely to be significant in the new drug discovery area considering the sheer value and prospects of the diabetes market. Currently, the Type 2 diabetes mellitus market is dominated by Novo Nordisk (Denmark) and Eli Lilly (U.S.) in insulins, by Takeda (Japan) and GSK in thiazolidinediones (TZDs), and by Eli Lilly in incretin mimetics. Others vying for a piece of the market include Sanofi-Aventis (France), Pfizer (U.S.), Novartis (Switzerland), and Merck (U.S.).

Related Articles

• United Kingdom: 22 May 2007: GSK Strongly Defends Avandia After Study Links It to Increased Heart Attack Risk
• United States: 31 March 2008: ACC Outcome to Deepen Merck, Schering-Plough's Vytorin and Zetia Troubles

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