Weekly Roundup 3.28.14

You know I’m busy when I don’t even have time for the Weekly Roundup.  I have had a very heavy travel schedule and a workload that has been quite a heavy one.  And sadly, there is no letup in sight for the next few weeks.  On the bright side, we seem to be past the weekly snowstorm conditions, at least here in the Mid-Atlantic states.

Fortunately this seems to coincide with the fact that FDA is running at a particularly slow pace.  The Office of Prescription Drug Promotion (OPDP) has managed to only eek out 2 letters so far this year.  There hasn’t been a press release all week until today, and there have not been any interesting speeches or testimonies submitted for quite a while.  So while I’ve been distracted, it has come perhaps at a good time.  I will be including some of the events from the week prior given that last week, I missed the Weekly Roundup.

  • New Hemophilia B Agent with Less Frequent DosingFDA today approved the first long-acting recombinant coagulation Factor IX for use in adult Hemophilia B patients.  The product, Alprolix, was approved to help control bleeding episodes and as a prophylaxis to prevent them.  Alprolix is another in what has been a long line of orphan drug approvals recently by FDA, with Hemophilia B affecting approximately 3300 patients in the U.S.
  • Migraine Prevention Drug for Adolescents – Also today, the agency announced approval of a drug for use in the prevention of migraines in adolescents called Topamax.  First approved in 1996 to prevent seizures and then approved in 2004 for prevention of migraines in adults, it is now being authorized for adolescents.  The product will come with a MedGuide.
  • Approval for Patients with Psoriatic Arthritis – From last week, a new treatment option was approved for patients with psoriasis who develop arthritis. Treatment options until now included corticosteroids, TNF blockers and an interleukin inhibitor.  Otzela is an inhibitor of phosphodieasterase-4 (PDE-4). The release advises that patients who are on the treatment should be monitored for weight loss during use.

That’s it for me.  Hopefully soon I will have more time.

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