Jon Arch article on novel anti-obesity drugs and satisfying the regulators
9 January 2008
An article by Jon Arch, Deputy Director of Metabolic Research, Clore Laboratory, University of Buckingham, UK, on strategies with novel anti-obesity drugs is featured in the January issue of The Diabetes Report, published by Espicom Business Intelligence.
Jon’s title was ‘How might regulators’ expectations of novel anti-obesity drugs be achieved?’ He reviewed how orlistat, sibutramine and rimonabant meet – or fail to meet – the FDA draft guidance and EMEA draft guidelines for weight loss, fat loss, visceral fat loss and improved metabolic status. In rodents and humans β3-adrenoceptor agonists cause loss of fat but not lean tissue, and they improve insulin sensitivity beyond expectations from weight loss. (In humans some of the compounds may also stimulate β2-adrenoceptors.) Jon argues that this is because β-adrenoceptor agonists stimulate fat oxidation and that other targets that are linked to fat oxidation may bring the same benefits.
Since regulators currently discount diabetes benefits that are due to weight loss if a drug has already been registered for obesity, it seems best to register the drugs for diabetes first and claim weight loss as an added benefit rather than register for obesity and then seek a diabetes claim.
The reference is:
Jonathan R S Arch ‘How might regulators’ expectations of novel anti-obesity drugs be achieved?’The Diabetes Report Espicom Business Intelligence, Feature Article – Anti-Obesity/Anti-Diabetes Drugs, Issue No. 24, January 2008