Weekly Roundup – 12/07/07

J0407411 We had our first snow fall inside the Beltway.  It was pretty and we were spared the more rigorous weather of Chicago.  Today we have a fine sleet that is coming down over the newly lit national Christmas tree – an event that snarled traffic for those of us trying to get home last night. 

Meanwhile, there was a lot of action with respect to new drugs and here is a bit of it –

  • Approvable Letter for Nebivolol – Forest Laboratories and Mylan received an approvable letter from the FDA for an anti-hypertensive drug already approved and available in 50 countries.  The drug in question, nebivolol, is seeking to be marketed under the name Bystolic(TM) is a beta blocker to treat hypertension.  According to the press release by Forest on the approvable letter, the agency was reacting to a recent inspection of a backup manufacturing facility in Belgium where it uncovered deficiencies.  Final marketing approval for nebivolol is said to be contingent upon satisfactory resolution of these deficiencies. The approvable letter did not raise any questions related to safety or efficacy of nebivolol. At this time, the companies and the FDA have agreed upon product labeling text.
  • Avastin® Has Close Vote at AC – On Wednesday, an FDA advisory committee voted 5-4 not to recommend approval for Genentech’s Avastin® (bevacizumab), already approved as a treatment for colon and lung cancer, as a first-line treatment for metastatic breast cancer.  Some may be hopeful that the FDA will, in the interests of approving a new cancer drug, ignore the advice of the panel, especially since it was a close vote.  According to the Genentech press release – "We believe that Avastin can help meet a significant unmet medical need for women with metastatic breast cancer, and we remain committed to working with the FDA to make Avastin a viable treatment option for these patients." Optimists should keep in mind, however, that the FDA review had indicated a skeptical view on the part of the agency regarding the drug. At serious issue here with this combined with the failure of Provenge to gain approval is how cancer drugs are judged and what endpoints are meaningful – an area that the FDA will have to make more clear in the future – particularly as decisions split into drugs and biologics, with two different committees having jurisdiction. 
  • Another Appeal of an FDA Decision – In what seems to be an increasing trend, yet another company has decided to appeal an FDA decision.  Cipher Pharmaceuticals, a Canadian company, is using the FDA’s Formal Dispute Resolution process in seeking to overturn an FDA decision issued in a May approvable letter for the drug CIP-TRAMADOL ER.  While the outcome for this particular company remains to be seen, turning to the Formal Dispute Resolution process is, in my opinion, a grasp at a straw.

That’s it for me this week folks.  Have a lovely weekend.


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