Albiglutide (Tanzeum): the withdrawn weekly GLP-1

Albiglutide is the cautionary tale of the class. It arrived in 2014 as a once-weekly drug, five months before dulaglutide, with a pen that needed reconstituting from powder and a potency that trailed the daily competitor it was compared against. It is listed as discontinued in Drugs@FDA, and its cardiovascular benefit was published after it had gone.

Mechanism and receptor profile

The Tanzeum label describes it as an agonistagonistA molecule that switches a receptor on, the way the body's own hormone would. of the GLP-1GLP-1A gut hormone released after eating that raises insulin, slows the stomach and reduces appetite; the medicines copy it and last much longer. receptor that augments glucose-dependent insulin secretion and slows gastric emptyinggastric emptyingHow quickly food leaves the stomach; these medicines slow it, which is part of why people feel full sooner.. The molecule is a fusion of GLP-1 sequences with human albumin; the albumin carries it for a week, the same idea as dulaglutide's antibody fragment and a different one from semaglutide's fatty-acid albumin binding. The label notes that carcinogenicity could not be assessed in rodents because albiglutide is not pharmacologically active in them, so its boxed warningboxed warningThe FDA's strongest label warning, printed in a box at the top; for these medicines it concerns thyroid C-cell tumours seen in rodents. is inherited from the class rather than from its own animal data, the same situation later faced by orforglipron.

FDA approval

One approval: 15 April 2014, BLA 125431, new molecular entity, as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes. The label carried a limitation of use, unusual for the class, stating it was not recommended as first-line therapy because of the uncertain relevance of the rodent C-cellC-cellThyroid cells that make calcitonin; rodent studies of these medicines showed tumours in them, which is why the boxed warning exists. tumor findings. Drugs@FDA lists the marketing status as discontinued and the final label revision as supplement 20, dated 20 December 2017.

Dosing as the label stated it

30 mg once weekly by subcutaneous injectionsubcutaneousInjected into the fat layer just under the skin, usually the abdomen, thigh or upper arm. in the abdomen, thigh or upper arm, at any time of day without regard to meals; may be increased to 50 mg weekly if the glycemic response is inadequate. The lyophilised powder was reconstitutedreconstitutionAdding sterile water to a powdered vial to make a solution that can be injected. inside the pen before use. Missed doses were to be taken within 3 days; the injection day could be changed if the last dose was 4 or more days earlier.

Pivotal trials and their numbers

Harmony Outcomes ended once the target number of events had accrued; the abstract records that patients were told to discontinue study treatment in November 2017, the month before the last label revision.

Adverse reactions from the label

Show the data9 rows: Tanzeum, label Table 1: pooled placebo-controlled trials, 923 patients exposed for a mean of 93 weeks

Tanzeum, label Table 1: pooled placebo-controlled trials, 923 patients exposed for a mean of 93 weeks

Adverse reaction	Placebo %	Tanzeum %
Upper respiratory tract infection	13.0	14.2
Diarrhea	10.5	13.1
Nausea	9.6	11.1
Injection site reaction	2.1	10.5
Cough	6.2	6.9
Back pain	5.8	6.7
Arthralgia	6.4	6.6
Sinusitis	5.8	6.2
Influenza	3.2	5.2

Two things stand out against the rest of the class. Nausea was barely above placebo, which the HbA1cA1cA blood test that reflects average blood sugar over roughly the past three months. results suggest came at the cost of potency. And injection-site reactions at 10.5% were five times placebo.

Boxed warning

The class thyroid C-cell tumor warning, with the label's own admission that carcinogenicity could not be assessed in rodents. ContraindicatedcontraindicationA condition listed on the label under which the medicine should not be used. with a personal or family history of medullary thyroid carcinomamedullary thyroid carcinomaA rare thyroid cancer arising from C cells; a personal or family history is a listed contraindication. or MEN 2MEN 2An inherited condition that raises the risk of medullary thyroid cancer; a listed contraindication for these medicines.. Other warnings: pancreatitispancreatitisInflammation of the pancreas, felt as severe upper-abdominal pain; the labels say to stop the medicine if it is suspected., hypoglycemiahypoglycemiaBlood sugar falling too low; uncommon with these medicines alone but more likely alongside insulin or a sulfonylurea. with insulin or secretagogues, hypersensitivity, acute kidney injury.

Status and manufacturer

GlaxoSmithKline. Discontinued per Drugs@FDA. The approval remains on the record, so albiglutide is "approved but not marketed" rather than "unapproved", a distinction the approved, investigational and compounded guide explains.

Where next

Dulaglutide, approved five months later with a ready-to-use pen and a stronger HbA1c result, is the product that took the market albiglutide was built for.