UPDATE 1-Study of Glaxo platelet drug halted due to clots

* FDA says Promacta study in liver patients halted

* Says more patients on drug got clots vs those on placebo

* Cautions drug not approved for those with liver disease
(Previous dateline WASHINGTON)

By Ransdell Pierson

NEW YORK, May 12 (BestGrowthStock) – U.S. regulators said on
Wednesday a study among liver-disease patients taking
GlaxoSmithKline’s (GSK.L: )(GSK.N: ) Promacta treatment for low
blood platelets was halted due to blood-clot safety issues.

The medicine is approved in the United States for treatment
of chronic immune idiopathic thrombocytopenic purpura (ITP), a
condition in which patients have abnormally low blood-platelet
counts for no known cause — putting them at risk of bruises or
serious bleeding.

The U.S. Food and Drug Administration said the halted
trial, called ELEVATE, involved patients whose low platelets
were due to a known cause: liver damage. The agency, in a
notice on its website, said the study was halted after a higher
incidence of blood clots was seen in patients taking Promacta
than those who received placebos.

Six patients, or 4 percent of patients receiving Promacta,
and one patient, or 1 percent of those receiving placebos,
experienced blood clots in an important blood vessel system
that connects to the liver, called the Portal Venous System,
the FDA said.

The FDA said it and Glaxo have reminded healthcare
professionals that Promacta is not approved for treatment of
patients with ITP that have chronic liver disease.

Platelets are one of the three main components of the
blood, and are necessary for the normal blood-clotting

“Exercise caution when administering Promacta to patients
with hepatic (liver) disease,” the alert advised doctors,
including use of a lower starting dose in patients with
moderate to severe liver disease.

Promacta, approved by the FDA in late 2008 and developed in
partnership with Ligand Pharmaceuticals Inc touted by Wall Street as a potential big seller. But it has
annual sales of less than $50 million.

Shares of Glaxo closed up 0.08 percent at $35.40 on the New
York Stock Exchange. Ligand shares rose 3 cents to $1.69 on

Stock Market News

(Reporting by Ransdell Pierson; Additional reporting by
Susan Heavey; Editing by Richard Chang)

UPDATE 1-Study of Glaxo platelet drug halted due to clots