Posts tagged ‘Chelsea Therapeutics’

NORTHERA (droxidopa) Advisory Committee Meeting

On Thursday, Feb 23, 2012, the FDA Cardiovascular and Renal Drugs Advisory Committee will meet to discuss Chelsea Therapeutics NORTHERA (droxidopa) NDA for use in the treatment of some very specific aspects of orthostatic hypotension.  Chelsea asked for and was granted Orphan Drug designation.

The drug seems to have a positive short term effect but there are a lot of serious concerns about safety, both from data that have been reported in the clinical trials and from post marketing reports from Japan where it is approved although at a lower dose.  At least equally important to making a decision are the unanswered questions about efficacy and safety.  The FDA has listed the known problems as well as the deficiencies in the data base in their briefing document and conclude that the drug is not ready for approval.
The Advisory Committee will likely agree with the FDA conclusion on this drug.

FDA Advisory Committee Schedule

As promised earlier, we are providing a more detailed listing of upcoming FDA Advisory Committee Meetings.

Of particular interest, Vivus‘s QNEXA is scheduled to be reviewed on Feb 22, 2012 by the Endocrinologic and Metabolic Committee for weight management.  Equally important, the FDA has scheduled another meeting of the Endocrinologic and Metabolic Committee for March 28-29, 2011.  Could it be that we might hear some discussion on revised guidelines?

Jan 30-31, 2012 Pediatric Advisory Committee Meeting

  • The Committee will discuss the status of the development of a number of drugs for pediatric use.

Feb 8-9, 2012  Oncologic Drugs Advisory Committee Meeting
The Committee will discuss:

  • XGEVA (denosumab) by Amgen for castrate resistant prostate cancer.
  • DACOGEN (decitabine) by Eisai for acute myelogenous leukemia.
  • PIXUVRI (pixantrone dimaleate)  by Cell Therapeutics for Non-Hodgekins Lymphoma

Feb 10, 2012  Cellular, Tissue and Gene Therapies Advisory Committee Meeting

  • No products are currently on the schedule for review.

Feb 10, 2012  Neurological Devices Panel Advisory Committee Meeting

  • No products are currently on the schedule for review

Feb 22, 2012  Endocrinologic and Metabolic Advisory Committee Meeting

  • The committee will discus QNEXA by Vivus for weight management

Feb 23, 2012  Cardiovascular and Renal Drug Advisory Committee Meeting

  • The committee will discuss NORTHERA by Chelsea Therapeutics for neurogenic orthostatic Hypotension.

Feb 27, 2012  Dermatologic and Ophthalmic Drugs Advisory Committee Meeting

March 12, 2012  Arthritis Advisory Committee Meeting

March 14, 2012  Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee Meeting

March 28-29, 2012  Endocrinologic and Metabolic Advisory Committee Meeting.