Merck gets an early Christmas Gift from the FDA
This morning Takeda announced the Food and Drug Administration (FDA) would complete a review of alogliptin a key diabetes drug candidate by June 26, 2009. Alogliptin belongs to a new class of diabetes drugs called DPP-4 inhibitors, and Takeda hopes it will compete with rival drug Januvia from Merck (NYSE:MRK). According to the company the delay is due to internal constraints at the FDA and is not related to any issues with the drug. This is the second time approval of alogliptin has been delayed due to internal issues at the FDA.
This announcement continues Merck’s incredible lucky streak with Januvia which has seen its market share increase as possible competition continues to face FDA delays or have been pulled from the approval process. Given the new guidelines for diabetes drug recently implemented at the FDA look for Januvia’s lucky streak to continue.
Although a rather lackluster drug Januvia is one of the few diabetes drugs that has yet to be tainted by reports of serious adverse events. Avandia sales plummeted due to concerns over adverse cardiovascular events. Both Avandia and Actos have been associated with increased incidence of bone fractures and Byetta has been linked to pancreatitis.
Diabetic Investor finds it curious that no one seems to care that Januvia itself has already had one label change in regards to a serious form of skin cancer. As Diabetic Investor has reported in the past some researchers are concerned that the skin cancer issue is just the tip of the iceberg for Januvia and long term usage of the drug may lead to other forms of cancer. This concern has been reinforced as many believe the FDA approved Januvia too quickly and did not examine more closely the possible link between DPP-4’s and cancer. Should these concerns prove accurate, combine them with the recent flap over diabetic drug usage and adverse cardiovascular events and you have a nightmare scenario. This will only strengthen the public’s belief that the agency cannot be trusted. Worse it could lead to patients to stop taking medications not associated with any serious adverse events something that occurred after the Avandia controversy became public.
For now Merck continues to position Januvia as a safe and effective therapy option although the data backing up these claims is suspect at best. Januvia is not an oral form of Byetta which Merck sales rep claim it is. Looked at side by side, Byetta is more effective at controlling glucose levels and has the added benefit of weight loss. Used as a monotherapy Januvia produces only minor improvements in A1C, it’s only when used in conjunction with metformin do we see significant improvements in A1C. Based on numerous patient and physician interviews Diabetic Investor has also learned that there is a higher than normal non-responder rate with Januvia. Yet even with all this the drug continues to perform well in the marketplace mainly due to the fact physicians are running out of options to effectively treat their type 2 patients and are reluctant to transition these patients to injectable therapy options such as insulin or Byetta.
In the long run Diabetic Investor truly hopes that we are dead wrong about Januvia and long term usage of the drug does not confirm the concerns held by many respected researchers. However, as we have seen with both Avandia and Actos, adverse events can surface long after the drug has been on the market.
Santa came early for Merck while Takeda got a big lump of coal in their stocking.