PharmExec Blog

InterMune Denied Approval for Lung Treatment

Lungs diagram with internal details
Image via Wikipedia

Biotech firm InterMune took an ugly hit on Tuesday as news broke that its lung disease drug Esbriet (pirfenidone) will require additional clinical studies, and won’t be getting the seal of approval from FDA any time soon. The news caused InterMune’s stock to drop a staggering 78 percent, according to Reuters. Analysts have downgraded the stock to values as high as $60 and as low as the mid-teens.

Esbriet is being used in trials to treat patients suffering from idiopathic pulmonary fibrosis (IPF), a debilitating and deadly lung infection that causes inflammation and scarring. People suffering from the disease typically have only two to five years to live and a 20 percent survival rate.

The treatment was involved in two large-scale clinical trials, but the drug failed to meet its endpoints in one. However, the Phase III data that the company collected was expected to be enough to get the green light from FDA.

In a complete response letter to InterMune, FDA requested another clinical trial to further prove the efficacy of Esbriet, beyond the endpoint met in the previous study. There are currently no FDA-approved medications for IPF, and an FDA advisory committee recommended that the treatment be approved back in early March.

Dan Welch, chairman, CEO and president of InterMune, said that he intends to meet with FDA as soon as possible to find out why its committee rejected the drug, and understand how to expedite the approval process. The bad news is that the meeting may not occur for 60 to 90 days.

Welch would not elaborate on the kind of data FDA would like to see, or what type of trial the regulatory body is looking for, nor would he comment on previous discussions with FDA.

Reblog this post [with Zemanta]
This entry was posted in FDA, Strategy and tagged , , , , , , . Bookmark the permalink. Trackbacks are closed, but you can post a comment.

One Comment

  1. Roy Smith
    Posted May 6, 2010 at 7:46 am | Permalink

    Too bad for these patients suffering from this dismal disease. Currently they have nothing (lung transplant, maybe). This is a growing crisis in the world and in the USA (IPF), and needs urgent attention. Following 911, many of the rescue workers are doomed with this disease.

Post a Comment

Your email is never published nor shared. Required fields are marked *


You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

  • Categories

  • Meta