FDA Pharma Meetings for February
Brandy is a member of The Motley Fool Blog Network -- entries represent the personal opinion of the blogger and are not formally edited.
FDA committees are comprised of independent experts who review the efficacy and risks of a submitted drug before making a recommendation. The FDA can choose to ignore this recommendation when handing out the final verdict at a later date. Failure to win approval from a committee, however, can lead to stock turbulence. Just ask Columbia Laboratories.
This list only includes drugs presented by companies listed on Nasdaq or the NYSE. For a full list of meetings, check the official calendar. Meeting materials are presented on their respective sites no later than two days prior to the meeting.
February 8 & 9: Oncologic Drugs Advisory Committee (Day One) (Day Two)
On the first day, Amgen (NASDAQ: AMGN) seeks approval for a supplemental NDA that would expand the indications for Xgeva to include preventing the spread of prostate cancer to the bones. Xgeva won FDA approval in 2010 for preventing fractures caused by cancer that had already spread to the bones. Final FDA decision will be issued April 26.
The following day has Cell Therapeutics and its resubmitted NDA for Pixuvri, a proposed treatment for advanced non-Hodgkin’s lymphoma that hasn't responded to other treatments. The original NDA was essentially denied in April 2010, with the FDA requesting further trials to determine risks and efficacy. Cell Therapeutics petitioned that decision and won, sparing the need for further trials but requiring an independent radiological review to take place before resubmitting. Final FDA decision will be issued April 24.
February 22: Endocrinologic and Metabolic Drugs Advisory Committee
The VIVUS (NASDAQ: VVUS) manufactured obesity drug Qnexa will be evaluated by the committee. The NDA for Qnexa was submitted in October 2011 but the FDA requested resubmission with a completed Risk Evaluation and Mitigation Strategy. The resubmission was accepted in November. Earlier this month, the FDA allowed Qnexa to remove a contraindication warning that women of "childbearing potential" shouldn't take the drug. Contraindications remain for pregnant women. Final FDA decision will be issued April 17.
February 23: Cardiovascular and Renal Drugs Advisory Committee
The committee will consider a NDA from Chelsea Therapeutics (NASDAQ: CHTP) for the drug Northera, proposed for treating symptomatic neurogenic orthostatic hypotension in patients suffering primary autonomic failure due to underlying conditions such as Parkinson's . The NDA was filed, alongside a Priority Review request, in September 2011. The Priority Review status was granted so the accelerated FDA ruling will come on March 28.
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