FDA expands Glaxo-Ligand Promacta to hepatitis C patients

Tue Nov 20, 2012 2:22am IST

A GlaxoSmithKline logo is seen outside one of its buildings in west London, February 6, 2008. REUTERS/Toby Melville

A GlaxoSmithKline logo is seen outside one of its buildings in west London, February 6, 2008.

Credit: Reuters/Toby Melville

Related Topics

Stocks

   
Priyanka Gandhi Vadra, daughter of Congress party chief Sonia Gandhi, adjusts her flower garlands as she campaigns for her mother during an election meeting at Rae Bareli in Uttar Pradesh April 22, 2014. REUTERS/Pawan Kumar

Election 2014

More than 814 million people — a number larger than the population of Europe — are eligible to vote in the world’s biggest democratic exercise.  Full Coverage 

(Reuters) - GlaxoSmithKline Plc said U.S. health regulators had approved its drug Promacta for the additional use of treating low platelet count in hepatitis C patients that will allow them to undergo a standard therapy for the liver disease.

The drug, already approved as a treatment for idiopathic thrombocytopenic purpura — low platelet count of unknown cause — was developed along with Ligand Pharmaceuticals Inc.

Ligand shares rose as much as 17 percent in heavy volumes by mid-day on the Nasdaq.

"We believe that Promacta sales are set to see an uptick with approval in a significant population with unmet medical need," Roth Capital analyst Joseph Pantginis said in a note.

About 3.2 million people in the United States have chronic hepatitis C, the most common blood-borne virus, according to the U.S. Centers for Disease Control and Prevention.

Pantginis estimated Promacta sales of $328 million in 2013, corresponding to $24.6 million in revenue for Ligand.

"We maintain our belief that Glaxo is committed to growing the Promacta franchise with approval in additional indications with about 20 clinical trials ongoing," the analyst added.

The drug, also known as eltrombopag, is approved in 90 countries and is marketed under the brand name Promacta in the United States and as Revolade elsewhere.

It is now the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based hepatitis C therapy due to low platelet counts.

The U.S. Food and Drug Administration's approval was based on results from two late-stage studies that collectively enrolled 1,521 patients.

(Reporting by Prateek Kumar in Bangalore; Editing by Saumyadeb Chakrabarty)

FILED UNDER:
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.

  • Most Popular
  • Most Shared

Fighting TB

REUTERS SHOWCASE

Only For Adults

Only For Adults

FDA moves to ban sales of e-cigarettes to minors.  Full Article 

For Diabetics

For Diabetics

Weight loss plan better than usual diet for diabetes patients.  Full Article 

Depends On DNA

Depends On DNA

Aspirin's benefit in preventing colon cancer depends on DNA.  Full Article 

STD Risk

STD Risk

Could shared sex toys transmit HPV?  Full Article 

Marijuana Use

Marijuana Use

France sees small increase in pot-related heart problems.  Full Article 

Internet Effect

Internet Effect

Retirees who use the Internet less likely to be depressed: study.  Full Article 

Reuters India Mobile

Reuters India Mobile

Get the latest news on the go. Visit Reuters India on your mobile device.  Full Coverage