GLP‑1 news from 2020
15 dated, sourced GLP-1 developments from 2020: approvals, trial results, prices, lawsuits, compounding and culture.
- Business
Emisphere Technologies acquisition completes for $1.35 billion
Novo Nordisk bought Emisphere and its SNAC absorption-enhancer technology, the platform that makes oral semaglutide tablets possible. It underpins both Rybelsus and the 2026 Wegovy pill.
- FDA & regulation
FDA approves Saxenda for adolescents 12 and older, the first GLP-1 drug for pediatric weight management
Liraglutide 3.0 mg (Saxenda) became the first GLP-1 receptor agonist approved in the US for weight management in patients aged 12 and older with obesity, based on the 56-week SCALE TEENS randomized trial in 251 adolescents.
- Business
Imcivree (setmelanotide) approved for rare genetic obesity
Rhythm Pharmaceuticals' MC4R agonist is approved for obesity due to POMC, PCSK1 or LEPR deficiency, later extended to Bardet-Biedl syndrome. Approval date confirmed in Drugs@FDA (NDA 213793, original approval November 25, 2020; FDA announcement November 27, 2020). It is the first obesity drug targeted at a specific genetic cause rather than at appetite in general.
- Business
Chugai and Lilly publish how orforglipron activates the human GLP-1 receptor
A joint paper in the Proceedings of the National Academy of Sciences described the structural basis for GLP-1 receptor activation by LY3502970, the first orally active nonpeptide agonist of the receptor. It established that a small molecule could do what only peptides had done before.
- Research
Setmelanotide phase 3 results published for POMC and LEPR deficiency
The Lancet Diabetes & Endocrinology published two single-arm, open-label trials of setmelanotide in 21 patients total. Eight of 10 with POMC deficiency and 5 of 11 with LEPR deficiency lost at least 10 percent of body weight in about a year, and hunger scores fell 27 and 44 percent. The FDA approved Imcivree six weeks later.
- Research
ADA publishes the first practical guidance on switching between GLP-1s
A Clinical Diabetes review by Almandoz and colleagues sets out why clinicians switch patients between GLP-1 receptor agonists and how to manage the transition, noting that pharmacy data suggest up to a quarter of patients leave their first GLP-1 within a year. There is still no FDA-approved conversion chart between different GLP-1 molecules.
- Science
Tirzepatide defined as an 'imbalanced and biased' dual agonist
Willard et al. publish in JCI Insight, establishing a method for calculating receptor occupancy at clinical doses and showing tirzepatide engages the GIP receptor more than the GLP-1 receptor while favoring cAMP over beta-arrestin at the GLP-1 receptor. The vocabulary from this paper is still the standard.
- Business
Novo Nordisk buys Corvidia Therapeutics, acquiring ziltivekimab
Novo Nordisk agreed to pay $725 million upfront, up to $2.1 billion with milestones, for AstraZeneca spin-off Corvidia and its anti-interleukin-6 antibody ziltivekimab. The drug would fail its main cardiovascular outcomes trial six years later.
- Science
Tirzepatide's gastric emptying effect is shown to fade with repeat dosing
Urva et al. report in Diabetes, Obesity and Metabolism that tirzepatide delays gastric emptying about as much as semaglutide in mice, that the effect disappears after two weeks, and that a long-acting GIP analog alone has no effect on gastric emptying at all.
- Research
SCALE TEENS published: liraglutide reduces BMI in adolescents with obesity
The New England Journal of Medicine published SCALE TEENS, a 56-week randomized placebo-controlled trial in 251 adolescents aged 12 to 17 with obesity (125 liraglutide 3.0 mg daily, 126 placebo). The primary endpoint, change in BMI standard-deviation score, favored liraglutide by an estimated -0.22 (95 percent CI -0.37 to -0.08, P=0.002); the estimated difference from placebo was -4.64 percentage points for BMI and -4.50 kg for body weight. It was the evidence base for the December 2020 Saxenda adolescent approval.
- Business
SUSTAIN 10 quantifies the semaglutide advantage over liraglutide
A 577-patient trial found semaglutide 1.0 mg weekly lowered A1C by 1.7 points and weight by 5.8 kg at 30 weeks, versus 1.0 point and 1.9 kg for liraglutide 1.2 mg daily. Semaglutide also caused more gastrointestinal side effects and more discontinuations, 11.4 percent versus 6.6 percent.
- Competition
FDA requests withdrawal of lorcaserin (Belviq) over a cancer signal
The CAMELLIA-TIMI 61 cardiovascular safety trial of about 12,000 patients over five years found cancer in 7.7% of lorcaserin recipients versus 7.1% on placebo, with pancreatic, colorectal and lung cancers more frequent. Eisai agreed to withdraw while stating its interpretation differed from the FDA's. Approval was withdrawn effective 2020-09-17.