Drug approvals: more numerous but niche

After several lean years, more than 30 new drugs were approved in 2012 by the EMA. Dr Sarah Houlton looks at the new entries on the market.

After many years of low approval rates, in 2012 more than 30 new drugs were approved by the European Medicines Agency – nearing 40 if vaccines are included. However, in line with the trend for increasing numbers of ‘niche’ products being developed, few have the potential to become very big sellers.

That said, there are numerous new medicines with indications for diseases that affect large populations and where new and more effective treatments are very much needed – such as diabetes. With Type II diabetes reaching almost epidemic proportions in the developed world, where diets have become poorer and lifestyles more sedentary, there is a real need for new therapies that give better control of blood sugar levels. However, diabetes drugs are not cheap to develop – in the light of the serious side-effects seen with rosiglitazone (Avandia), regulators now expect ever larger trials to be carried out that will increase the possibility of safety signals being pinpointed before the drug reaches the market.

This has not stopped the pharma companies working in the area, though partnership to defray the huge costs is increasingly common. This was the case with dapagliflozin (Forxiga), where development was carried out by Bristol-Myers Squibb and AstraZeneca. The first-in-class medicine is a competitive, reversible, selective and orally active inhibitor of the human sodium-glucose co-transporter 2, or SGLT2. Its antidiabetic effect is a result of the reduction in the reabsorption of glucose in the kidney, with the glucose being excreted in the urine instead. Perhaps unsurprisingly, bearing in mind the Avandia debacle, the regulator demanded that a pharmacovigilance plan should be put in place.