Januvia – The Streak Continues
Given what’s going on with Lantus another key piece of diabetes news may have gone largely unnoticed over the weekend when Takeda said on Saturday alogliptin, their DPP-4 inhibitor, failed to receive FDA approval. According to the company the FDA has asked for additional safety tests, which could take at least two years to complete.
The company also stated they would delay seeking European approval for alogliptin until 2012. The company originally planned to submit the drug in Europe this year but has decided to conduct another study before submitting the drug.
This news leaves Januvia from Merck (NYSE:MRK) as the only FDA approved DPP-4 inhibitor on the market and continues one of the luckiest streaks ever.
Alogliptin now joins Galvus as a potential competitor to Januvia that failed to make through the FDA. Some may say that alogliptin is a victim of bad timing being the first drug for type 2 diabetes to be considered by the FDA after the Avandia controversy and there may be some truth to this. However, this news does make one wonder how Januvia got through the FDA so quickly.
As regular readers of Diabetic Investor know we do not hold a high opinion of Januvia when used as a monotherapy. Looking over all the available data and based on interviews with physicians, used alone Januvia produces rather lackluster results. Patients who use both Januvia and metformin or Janumet (Januvia and metformin in a single tablet) have seen much better results. We have also noted that Januvia has also undergone a label change regarding a serious form of skin cancer.
Still the drug has achieved blockbuster status and will likely continue on this path for some time as physicians are running out of treatment options for their type 2 patients. Given the direction of research into diabetes therapy options Merck would be well advised to maximize Januvia sales while they can. As we have seen with Avandia and Actos where bone fracture complications showed up nearly seven years after the drugs where on the market and as we have seen with Lantus which was approved back in 2000, no drug is safe from the scrutiny of researchers who seem hell bent on finding flaws with every diabetes therapy available.
Up to this point Januvia remains one of the luckiest diabetes drugs to come market. However, Merck should remember the words of Bret Harte; “The only sure thing about luck is that it will change.”