Ariad to relaunch leukemia drug with new warnings (Update)

Ariad Pharmaceuticals has received approval to relaunch its leukemia drug Iclusig after addressing safety concerns raised by U.S. regulators in October.

Company shares jumped more than 20 percent.

Ariad added new warnings about potential blood clots and the risk of heart failure to the drug's label. Additionally the company revised prescribing information on which patients should receive the drug. Ariad expects to resume marketing by mid-January.

The Food and Drug Administration asked the company to halt sales and promotion of the drug, citing the danger of life-threatening blood clots.

Under a new risk management plan, the company is required to educate doctors about the drug's blood clot risks and new prescribing indication. Additionally, the FDA is requiring Ariad to track blood clot rates in patients taking Iclusig across several studies.

The re-entry of the drug earn a $3 price target increase from Stifel Nicolaus, to $10. Shares rose $1.19 to $6.71 by midafternoon.

"We see quick uptake in sales and revise our 2014 sales estimates to $125 million from $120 million," wrote analyst Joel Sendek.

Related Stories

Iclusig approved for rare leukemias

date Dec 16, 2012

(HealthDay)—Iclusig (ponatinib) has been approved by the U.S. Food and Drug Administration to treat two rare forms of leukemia..

US overturns safety limits on diabetes drug

date Nov 25, 2013

The U.S. Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart ...

Experimental diabetes drug makes comeback

date Dec 12, 2013

A panel of federal health advisers has backed the benefits of an experimental diabetes drug that uses a new method to reduce blood sugar, setting aside previous concerns about the pill's safety.

Recommended for you

Rising antibiotic shortages raise concerns about patient care

date Apr 23, 2015

Shortages of key antibiotics, including gold-standard therapies and drugs used to treat highly resistant infections, are on the rise, according to a new study of shortages from 2001 to 2013 published in Clinical Infectious Di ...

Study supports HPV vaccination guidelines

date Apr 21, 2015

(HealthDay)—New research finds that young women who get the HPV vaccine gain significant protection against infection in three parts of the body if they haven't already been exposed to the human papillomavirus.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.