LONDON-- GlaxoSmithKline PLC's diabetes treatment albiglutide
was approved for use by U.S. regulators on Tuesday, after a series
of drug-development setbacks for the company.
Albiglutide was approved for use in Europe in March under the
brand name Eperzan. It belongs to a class of drugs called GLP-1
receptor agonists, which work by stimulating the body's natural
production of insulin and help regulate blood-sugar levels.
Glaxo expects the drug to be launched in the U.S. under the
brand name Tanzeum in the third quarter of this year. Despite
approval, Glaxo's drug is likely to face stiff competition from
rivals that work in a similar way.
GLP-1 drugs are prescribed to people with Type 2 diabetes,
usually when attempts to control the disease through diet and
exercise have failed but when patients don't yet need insulin
injections. Type 2 diabetes gets progressively worse with time,
especially if blood sugar levels aren't well managed.
The leading drug prescribed for this type of treatment is
Victoza from Novo Nordisk A/S, which must be injected every day.
Albiglutide could prove to be more convenient for diabetics because
it is a once-weekly injection.
Another once-weekly injection, called Bydureon from AstraZenecal
PLC, is already available. However, Bydureon has had poor uptake
because a large needle is needed for the injection, although it has
recently been approved for use in the U.S. in an easier-to-use pen
device.
Market expectations for albiglutide are modest. Analysts at
Deutsche Bank are penciling in sales of just $360 million by 2018.
That compares with Victoza sales of some $2.1 billion last
year.
Albiglutide failed to beat Victoza in a head-to-head study in
2011, which measured the drug's efficiency at lowering the amount
of glucose in the blood.
Albiglutide could also face stiff competition from a drug
currently being developed by Eli Lilly & Co. called
dulaglutide, another once-weekly GLP-1 injection which showed
similar efficacy in a head-to-head study with Victoza. Dulaglutide
could be approved later this year.
Novo Nordisk is also working on a once-weekly injection of
GLP-1, called semaglutide.
Still, the approval is a positive for Glaxo, which halted
development of a cancer vaccine earlier this month after
disappointing clinical trial results.
In late March, it withdrew a regulatory application in Europe
for use of its ovarian-cancer treatment Votrient in a new group of
patients with the disease. And in November, it reported that a
heart-disease drug it is developing--once one of its brightest
pipeline hopes--had failed to show a meaningful effect on
patients.
Write to Hester Plumridge at Hester.Plumridge@wsj.com
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