Summary
- The success of ONGLYZA (saxagliptin) will largely depend on its long-term safety.
- Saxagliptin is the second drug from this class to be approved in Europe and the US - Merck's Januvia (sitagliptin) was the first.
- Saxagliptin has had to overcome several new regulatory hurdles as a result of major recent safety issues with other diabetes drugs including sitagliptin.
- Sceptical prescribers and heavy postmarketing scrutiny will likely mitigate a rapid uptake.
Analysis
The recently approved ONGLYZA (saxagliptin) will likely face a hefty dose of skepticism on the part of prescribers and heavy post-marketing surveillance on the part of regulators. One can only hope that both do not prejudge the drug before a robust evaluation of its longterm safety can be undertaken.
Nonetheless, the recent approval of ONGLYZA (saxagliptin) brings fresh hope for patients with type 2 diabetes. Saxagliptin is the second drug from this novel class - Merck's Januvia (sitagliptin) was the first - to be approved in the EU and US.
The path to approval for saxagliptin has not been easy. Over the past several years, hope for new diabetes drugs has been in short supply. Long-term safety data from a previously novel and exciting class of drugs, which include GlaxoSmithKline's Avandia were highly unfavorable. In December 2008, FDA guidelines for addressing the cardiovascular risk of diabetes drugs were introduced, dashing Takeda's hopes for a 2009 alogliptin approval.
More discouraging news for diabetes patients came a few weeks ago: FDA infomed patients and medical professionals about 88 post-marketing cases of acute pancreatitis (which can be a life-threatening illness with severe complications) associated with Merck's sitagliptin.
Whether acute pancreatitis is specific to sitagliptin or is a class effect, remains to be seen.
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
