Ariad to relaunch leukemia drug with new warnings (Update)

December 20, 2013

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.

Explore further: Ariad suspends sales of cancer pill Iclusig

Related Stories

Iclusig approved for rare leukemias

December 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

November 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

December 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.

J&J again seeks more approvals for clot blocker

September 7, 2012

(AP)—Johnson & Johnson has given the Food and Drug Administration additional data to on its new anticlotting drug, in a second attempt to get approval for more uses.

Recommended for you

Researchers identify source of opioids' side effects

January 17, 2017

A commercially available drug may help drastically reduce two side effects of opioid painkillers—a growing tolerance and a paradoxical increased sensitivity to pain—without affecting the drugs' ability to reduce pain, ...

CVS generic competitor to EpiPen, sold at a 6th the price

January 12, 2017

CVS is now selling a rival, generic version of Mylan's EpiPen at about a sixth of its price, just months after the maker of the life-saving allergy treatment was eviscerated before Congress because of its soaring cost to ...

Many misuse OTC sleep aids: survey

December 29, 2016

(HealthDay)—People struggling with insomnia often turn to non-prescription sleep remedies that may be habit-forming and are only intended for short-term use, according to a new Consumer Reports survey.

The pill won't kill your sexual desire, researchers say

December 15, 2016

Taking the pill doesn't lower your sexual desire, contrary to popular belief, according to research published in the Journal of Sexual Medicine. The authors of the research, from the University of Kentucky and Indiana University ...

0 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.