For the last five years, Phase III clinical trials for diabetes drugs have faced a new hurdle: proving cardiovascular safety. This comes after GlaxoSmithKline’s Avandia (rosiglitazone) disaster. Avandia was once the world’s best-selling diabetes pill, with more than $3 billion annual revenue. A potential link to heart attacks and other serious heart problems led to it being banned in Europe, and is now available in the U.S. through a very limited access program. Following questions about the cardiovascular safety of diabetes drugs, the FDA ruled that all new Type 2 diabetes drugs prove cardiovascular safety on top of demonstrating their ability to lower blood sugar.
Cardiovascular disease is the biggest cause of mortality among diabetics, so this move by the FDA makes sense. The problem for pharmaceutical companies is that adding the burden of demonstrating cardiovascular safety on top of glycemic control greatly increases drug development costs. The new regulation greatly expands the size and length of Phase III clinical trials. It could take more than 10 years to develop a new diabetes drug; the investment for pharmaceutical companies is huge.
It’s not all doom-and-gloom. Johnson & Johnson just won conditional FDA approval for its new first-in-class diabetes drug, Invokana (canagliflozin). The effort was huge, involving nine late-stage studies with more than 10,000 patients, breaking pharma R&D records. With ongoing cardiovascular trials, they’re not quite done, but it’s looking good.
Right now, drug development costs limit the field to Big Pharma. Smaller drug development outfits can’t raise the capital to bring drugs through clinical trials. They are either forced into partnerships with bigger pharmaceutical companies, or are unfortunately driven away from entering the market.
1. T. Staton. Pharmacies say goodbye to Avandia in November. FiercePharma. May 19, 2011.
2. L. Nainggolan. Heart-smart diabetes drugs: Pipe dream or possibility. TheHeart.org. March 28, 2013.
3. R. McBride. Updated: J&J wins first FDA approval for new class of diabetes drug. FiercePharma. March 29, 2013.