Arena / Locaserin – we can’t say they are not trying…….

Arena announced yesterday the submission of their complete response letter to the FDA, based on  the October 2010 Complete Response Letter.

Although every case should be judged on its own merit and circumstances, considerable parallels can be drawn from the Vivus discussion in this space last month.  The FDA has provided a path forward for each to respond to the Agency’s concerns, but will it be enough to outweigh the Agency’s risk assessment, real or perceived?

Neither Vivus nor Arena has much choice but to invest the resources and respond.  And maybe through a large risk mitigation program or an austere label, approval is possible, but it seems unlikely.   Efficacious and SAFE treatments for obesity are needed, but are these the best industry has to offer?

 

 

 

Advertisements
Post a comment or leave a trackback: Trackback URL.

Comments

  • banat  On January 11, 2012 at 12:59 am

    looks like good potential for lorcaserin?

    • metabolicmarkets  On January 11, 2012 at 5:27 pm

      We will see. I think the FDA have become experts at giving companies just enough rope to hang themselves. Arena was able to raise $33 million on the re-submission, likely just enough to keep them afloat until the FDA pulls the rug out from under them one more time, to add another metaphor.
      I just don’t think that locaserin has the data to support approval. I was blogging on this issue a few weeks ago about Qnexa, it feels like the FDA wants to approve an obesity agent, but are the ones in front of them the right ones from an FDA perspective?

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: