Skip navigation.
Home
Sat Jul 4 19:47:25 2009 | [Write for us] | [Subscribe to RSS] | [Advertise with us] [Editor's Blog]

FDA shelves decision on J&J psoriasis drug, seeks drug safety plan

New York, December 20: Holding back on the decision to approve Johnson & Johnson's psoriasis drug Ustekinumab, the US Food and Drug Administration (FDA) Friday issued a Complete Response letter for the drug requesting for additional risk-mitigation information.

While the federal regulators have not asked for more clinical data, avoiding a hefty delay in its approval, the agency has requested the pharma giant to provide a strategically designed plan detailing potential risks of the drug.

"The Complete Response letter requests additional information, including a proposal ... for a risk evaluation and mitigation strategy to ensure the drug's benefits outweigh its risks," J&J said detailing the requirements of the letter.

As per the Complete Response letter, the company will now design a medication guide and a communication plan that would detail the risks and benefits of the medication, proper technique of administration and ways to minimize adverse outcomes. It would be circulated among patients and doctors.

Ustekinumab, a monoclonal antibody designed to work by inhibiting a type of protein called interleukin, is believed to play a role in psoriasis, an autoimmune skin disorder triggered by the overproduction of skin cells.

The disorder is typically characterized by the appearance of red scaly patches that may itch and bleed. The condition is often painful. The condition affects an estimated 7.5 million Americans and 10 million Europeans.

In the latest drug data touted by the company, the experimental psoriasis drug helped achieve significant skin clearance in two subcutaneous doses as against a series of 24 subcutaneous doses of Enbrel, the signature treatment jointly already marketed by Wyeth and Amgen.

Though the advisory panel had unanimously recommended Ustekinumab for approval, concerns about an increased risk of infection, reactivate tuberculosis and cancerdefine still remained high.

However the company is confident that it can "expeditiously address the FDA's questions". Moreover, Jerome Boscia, senior vice president at Centocor, a unit of Johnson & Johnson that would market the drug, asserted, "We anticipate responding to the FDA in January 2009 and remain focused on bringing ustekinumab to market."

Post new comment

The content of this field is kept private and will not be shown publicly.
 
  • Web page addresses and e-mail addresses turn into links automatically.
  • Allowed HTML tags: <a> <em> <strong> <cite> <code> <ul> <ol> <li> <dl> <dt> <dd>
  • Lines and paragraphs break automatically.
  • Glossary terms will be automatically marked with links to their descriptions. If there are certain phrases or sections of text that should be excluded from glossary marking and linking, use the special markup, [no-glossary] ... [/no-glossary]. Additionally, these HTML elements will not be scanned: a, abbr, acronym, code, pre.

More information about formatting options

CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

For daily updates in your mailbox Subscribe for free via email, or grab our feed.
 

User login

I n   F o c u s
Tobacco has the potential to harm your health in more ways than one. Here are seven reasons to stay away from tobacco.
tobacco.jpg

Tobacco is bad for your health. Whatever be the method of consuming tobacco- fresh, processed or in the form of smoke, your health will be harmed significantly.

    Regular practice of certain yoga positions (asanas) can give tremendous boost to your sex life.
    beach_yoga_aw.jpg

    According to the Dec. 3, 2008 issue of the Journal of Sexual Magazine, yoga improved levels of arousal in sexually unsatisfied women. It helped them achieve better orgasm. The practice was also found to be effective in treating premature ejaculation in men.

      Making a man fall in love with you is rather easy, long as you know which buttons to push. Here’s a little tutorial for the clueless girls.
      lman.jpg

      You have just met your Mr. Right and with all your womanly intuition you feel that he is the one you have been waiting for. You are excited, can`t stop smiling and your cheeks turn red the moment he enters.

        LiveZilla Live Help