Obesity drugs have traditionally had a hard time in the R&D arena, with the FDA approving just two drugs for obesity since 1999 – Arena's Belviq and Vivus' Qsymia.
Now that the largest association of doctors in the US have voted that obesity should be recognised as "a disease, requiring a range of medical interventions", however, biopharma could see some significant changes in insurance coverage and research funding for obesity drugs. Here is a summarised list of some of the points raised by the AMA in their report which outlines the effect that the decision might have on biopharma:
- Greater investments by government and private sector to develop and reimburse obesity treatments
- Increased pressure on FDA to approve medications for obesity
- Reframing of the FDA approval process to focus on the ability of pharmaceuticals to decrease adipose tissue rather than to improve other markers of metabolic health (e.g. blood pressure and lipid levels).
- More effective medications on the market would likely spur physicians to prescribe, and patients to expect, pharmaceutical interventions for obesity
- 3rd party payers harder pressed to deny coverage
The AMA's move could be beneficial for companies such as Orexigen, who's prescription diet pill was rejected by the FDA back in 2011 (Top 5 Most Surprising Pharma Regulatory Agency Rejections). Do you think we will we see more obesity drugs entering the market?
If you want to know more about the detection, analysis and prevention of adverse drug reactions with case studies, industry experiences and global regulatory coverage of developments, you might be interested in attending the World Drug Safety Congress Europe 2013, 10-12 September 2013, London.