Galvus delay raises questions about drug class
On Monday, Merck likely welcomed the news that the FDA would require another round of testing for Novartis' Galvus, delaying the drug for up to a year. Galvus is slated to compete with Merck's Januvia in the lucrative diabetes market. The agency asked that Novartis mount a new study of the drug to assess kidney impairment. But the safety concerns the FDA expressed over Galvus could also pose a problem for Merck, as both drugs are part of a new class of medicines called DPP-4 inhibitors. If companies have learned anything from the Vioxx safety scandal, it's that it's important to watch for signs of trouble in competitor's drugs as well as your own.
There are several concerns about the safety DPP-4 inhibitors, including how they impact the immune system and the effect they might have on the kidney. However, both companies say neither of these theoretical side effects have shown up in clinical trials, though they will continue to monitor DPP-4 inhibitors for any signs of trouble.
- read the Forbes article for more