FDA Approves Onglyza
This afternoon the FDA approved Onglyza from Bristol Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN). Onglyza is just the second DPP-4 to be approved by the FDA and will face stern test in the market as Januvia from Merck (NYSE:MRK) has been the lone DPP-4 on the market for the past three years.
Before everyone hails this approval as a major achievement for patients with diabetes or trouble for Merck, it should be noted that there is nothing all that special about Onglyza. While the companies will do their best and differentiate the drug from Januvia, the differences are slight at best. They will also have the additional hurdle of overcoming Januvia. Had the two drugs come out within months of each other the story might be different.
Onglyza will also face even stiffer competition when Byetta LAR and Victoza reach the market. The fact is most physicians consider Januvia a rather lackluster drug when used as a monotherapy. While Merck reps have been calling Januvia an oral form of Byetta, it’s well known that Byetta has far superior performance.
Perhaps the best news here is that the FDA has actually approved a new diabetes drug. For sometime Diabetic Investor was beginning to wonder if we would ever see something approved given all the new guidelines. Let’s just hope the agency goes one step further and approves Victoza and Byetta LAR, that’s when the real fun will begin.
