GLP‑1 news from 2017
13 dated, sourced GLP-1 developments from 2017: approvals, trial results, prices, lawsuits, compounding and culture.
- Research
SUSTAIN 3 beats exenatide extended-release
Semaglutide 1.0 mg cut HbA1c 1.5% versus 0.9% and produced roughly three times the weight loss of exenatide ER over 56 weeks.
- FDA & regulation
FDA approves Ozempic, the first semaglutide product
The FDA approved Ozempic (semaglutide) injection to improve blood sugar control in adults with type 2 diabetes, alongside diet and exercise. It was the first approved product containing semaglutide and carried a boxed warning for thyroid C-cell tumors.
- Safety
Ozempic approved with a boxed warning for thyroid C-cell tumors
FDA approved semaglutide injection for type 2 diabetes with a boxed warning based on rodent thyroid C-cell tumors and an absolute contraindication in people with a personal or family history of medullary thyroid carcinoma or MEN 2. The warning and contraindication remain on every semaglutide product in 2026.
- Business
Bydureon BCise autoinjector approved
AstraZeneca wins approval under NDA 209210 for a simpler single-dose autoinjector version of weekly exenatide, an attempt to fix the original product's difficult mixing and injection process.
- FDA & regulation
FDA advisory committee votes 16-0 in favor of approving semaglutide
An FDA advisory committee voted unanimously to recommend approval of once-weekly semaglutide for type 2 diabetes. The unanimous vote cleared the last major hurdle before the agency's decision.
- Science
Semaglutide shown to delay first-hour gastric emptying in people with obesity
Hjerpsted and colleagues reported that semaglutide slowed stomach emptying in the first hour after a meal (acetaminophen AUC ratio 0.73 versus placebo) while leaving overall emptying similar. The finding still underpins how the label describes the gastric effect.
- Business
EXSCEL misses: weekly exenatide is not superior to placebo
The largest GLP-1 cardiovascular outcomes trial by enrollment, 14,752 patients, returns a hazard ratio of 0.91 with a p value of 0.06 for superiority. Exenatide never gains a cardiovascular indication, and the near-miss marks the beginning of its commercial decline.
- Science
First near-atomic structure of the activated GLP-1 receptor published
A cryo-electron microscopy structure showed the GLP-1 receptor bound to its G protein, with the peptide clasped between the receptor's N-terminal domain and its transmembrane core. It gave drug designers their first detailed picture of the target semaglutide would hit.
- Research
SUSTAIN 4 shows semaglutide beats insulin glargine on A1c and weight
Semaglutide produced 3.5-5.2 kg of weight loss while insulin glargine caused 1.2 kg of weight gain, with less hypoglycemia.
- Business
Three-year SCALE data shows liraglutide delays type 2 diabetes
The Lancet published 160-week results from 2,254 adults with prediabetes. Two percent of the liraglutide group versus 6% on placebo developed diabetes while on treatment, a hazard ratio of 0.21, with 6.1% versus 1.9% weight loss. Half the participants had left the trial by week 160.
- Research
SUSTAIN 1 published: first phase 3 semaglutide results
Weekly semaglutide lowered HbA1c by about 1.5 percentage points and body weight by 3.7-4.5 kg versus almost no change on placebo in drug-naive type 2 diabetes.
- Business
David Ricks becomes chief executive of Eli Lilly
Ricks, a 25-year Lilly veteran who had run Lilly Canada, Lilly China and Lilly USA, took over a company worth about $93 billion. He has said the early tirzepatide data arrived that year and that leadership recognized its potential immediately.
- Business
Lars Fruergaard Jorgensen becomes CEO as sales flatline at DKK 111.7 billion
Jorgensen took over a company whose net sales were essentially flat year over year at DKK 111.7 billion with operating profit of DKK 49.0 billion. Ozempic was approved in the United States the same year.