Last month, the Food and Drug Administration approved Tradjenta (linagliptin), an oral Type 2 diabetes drug made by German drug maker Boehringer Ingelheim and Indianapolis-based Eli Lilly. The drug belongs to the class known as dipeptidyl peptidase-4 inhibitors, which also includes Merck’s Januvia (sitagliptin). With diabetes affecting some 26 million Americans and growing rapidly, Drug Store News spoke with Wa’el Hashad, BI’s VP cardiovascular and metabolic disorders marketing, about what the approval of Tradjenta means for the diabetes market.
Drug Store News: What do you see as Tradjenta’s biggest advantages over other diabetes drugs in general, as well as over other DPP-4 inhibitors on the market?
Wa’el Hashad: Tradjenta is the first in its class to be approved at one dosage strength, so there is only one dose to remember for all patients. Tradjenta can be used as a stand-alone therapy or in combination with other commonly prescribed medications for Type 2 diabetes — including metformin, sulfonylurea or pioglitazone* — and has demonstrated reductions in hemoglobin A1C levels of up to 0.7% compared with placebo. The recommended dose of Tradjenta is 5 mg once daily, and it can be taken with or without food. With Tradjenta, no dose adjustment is recommended for patients with kidney or liver impairment. Tradjenta should not be used in patients with Type 1 diabetes or for the treatment of diabetic ketoacidosis, a disease that causes increased ketones in the blood or urine. It has also not been studied in combination with insulin.
We are confident in Tradjenta’s potential to compete effectively in the Type 2 diabetes market and are very excited to make Tradjenta available to the millions of people whose diabetes is not adequately controlled. The FDA’s approval of Tradjenta means physicians will have another option for treating their patients with Type 2 diabetes whose blood sugar is uncontrolled. Alternative treatment options are important because Type 2 diabetes can be difficult to manage, and it is often very personal, meaning treatment regimens need to address individual patient needs.
DSN: What is the drug’s greatest advantage from a patient and pharmacist perspective?
Hashad: Tradjenta is the first in its class to be approved at one dosage strength, so there is only one dose to remember for all patients. We recognize pharmacists play an important role in further educating patients about Tradjenta. Boehringer Ingelheim Pharmaceuticals and Eli Lilly are committed to ensuring primary care practitioners and pharmacists are aware of when Tradjenta becomes available and are able to educate patients appropriately.
DSN: What prompted BI and Lilly to develop Tradjenta together?
Hashad: Tradjenta was discovered by Boehringer Ingelheim. In January 2011, BI and Lilly formed a strategic alliance in diabetes. This cooperation gives BI and Lilly the combined benefits of Lilly’s expertise in the diabetes market and two basal insulin analogs, as well as BI’s rich and innovative late-stage pipeline. The alliance leverages the collective scientific expertise and business capabilities of two leading research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic.
DSN: How will the launch of Tradjenta affect the diabetes market in the years to come?
Hashad: The oral diabetes market is a $15 billion market, and DPP-4s are the fastest- growing segment of this market. We believe Tradjenta will further expand this growing market and bring a new treatment option to patients, healthcare providers and pharmacists.
* Pioglitazone is the generic name of Takeda’s Actos.