We are at a point with oral medications for diabetes where there are new drug approvals in recently approved classes, new drug classes where the first in class is approved, as well as late trial research moving quickly for drugs in yet unapproved classes. First it was the DPP-4 inhibitors with Januvia, Onglyza, Tradjenta and Nesina. Next was Cycloset and the new SGLT2-inhibitor, Invokana, recently approved as first in class. Now there is a class called GPR40-agonists of which fasiglifam, from Takeda, is the first to get far enough along in phase 3 trials to garner some interest.
GPR40 receptors appear to be closely involved in the pathology of various metabolic disorders including obesity, dyslipidemia, and type 2 diabetes, and could offer yet another drug class in the diabetes arsenal.
However with all these new classes and drugs one has to wonder if any of them will reach the blockbuster status that Januvia reached. According to Dr. Valentina Gburcik, Cardiovascular & Metabolic Disorders Analyst for the research and consulting firm, GlobalData, "While Takeda’s new drug shows promise, the lack of treatments tackling the condition’s root cause may result in the underwhelming market performance of individual drugs." She goes on to say, "We are entering an era in the diabetes market where the first-in-class drugs start in many ways to resemble ‘me-too’ drugs, despite their novel mechanisms of action. With some of the diabetes drugs going off patent, the prospect for future diabetes blockbusters becomes even bleaker due to eventual generic competition to the former blockbusters, and consequently, even more pronounced cost-effectiveness issues."
Dave Joffe, Editor-in-chief