“We are delighted with the approval of Trulicity,” the President of Lilly Diabetes Enrique Conterno said in a statement. “Lilly now has treatment options in several classes of diabetes medications: orals, GLPs and insulin. Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with Type 2 diabetes.”
GLP-1—short for glucagon-like peptide-1 receptor agonists—is a naturally occurring hormone released in the intestine that stimulates the release of insulin from pancreatic beta cells when carbohydrates are absorbed in the intestine. Additionally, GLP-1 is also present in the brain, where it acts as an appetite suppressant.
Trulicity, which is the brand name for the drug dulaglutide, will be available later this year as an injectable treatment with a single-use pen that doesn’t require mixing, or a needle attachment, the company said. It can be administered once a week, at any time of the day, regardless of mealtimes. Lilly recommends injecting Trulicity in the abdomen, the leg, or the upper arm.
Dr. Sherry Martin, a senior medical director at Lilly who was involved in clinical trials for Trulicity, conceded that for Type 2 diabetics now treating their condition with oral medication, using an injectable drug could be a daunting change because it “carries with it an increased burden of responsibility.” But, she said, when patients were ready to transition to an injectable treatment, she believed Trulicity would prove a more appealing option than the once daily regime of Victoza, another GLP-1 injectable that is the most popular treatment of its kind.
The FDA cautioned that Trulicity “should not be used to treat people with Type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); those with severe stomach or intestinal problems; or as first-line therapy for [Type 2 diabetes] patients who cannot be managed with diet and exercise.”
Martin said that the treatment has been in development for 10 years. This included multiple clinical trials over the last five years. According to both Martin and the FDA, Trulicity was tested in six clinical trials that evaluated 3,342 subjects with Type 2 diabetes who were given Trulicity. The treatment was tested as a stand-alone drug, as well as being used alongside existing treatments, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. The results revealed that, according to the FDA, “Patients receiving Trulicity had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control)” compared to using such treatments on their own.
Even though Trulicity has already undergone intensive rounds of testing, there is yet more testing that will follow. After the drug reaches the market, as part of its approval, the FDA said in a statement that the agency is “requiring the following post-marketing studies for Trulicity:
- a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients;
- a study to assess potential effects on sexual maturation, reproduction, and CNS development and function in immature rats;
- a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Trulicity;
- a clinical trial comparing Trulicity with insulin glargine on glycemic control in patients with Type 2 diabetes and moderate or severe renal impairment; and
- a cardiovascular outcomes trial to evaluate the cardiovascular risk of Trulicity in patients with high baseline risk of cardiovascular disease.”
Trulicity will join other GLP-1 treatments, both long and shorter acting, to compete for a slice of a market niche that is expected to expand from its current $3 billion a year valuation to $5 billion a year in the next few years, according to industry newsletter FierceBiotech. In March of this year the FDA approved a pre-filled, single use pen injector of AstraZeneca’s Bydureon, which was originally approved by the FDA as an injection in 2012. Novo Nordisk’s Victoza now commands 70 percent of the GLP-1 market with $2 billion in annual sales, FierceBiotech reports.
Trulicity is expected to compete to capture its share of the market by touting its once-a-week convenience and its no-assemble, easy-to-use pen. Test results have revealed, however, that Trulicity is lagging when it comes to being able to promise superior weight loss to Victoza. In one study, subjects taking Trulicity lost an average of 6.4 pounds during a 26-week course of treatment, while subjects in Victoza lost eight pounds.
However, Lilly is confident that the weight loss numbers won’t prove a significant deterrent to having their new drug succeed.
“The fact that it is administered once a week, and that it has proven effective in improving glycemic control, are the most important aspects of what Trulicity has to offer patients with Type 2 diabetes,” Martin said.