Eye on FDA

Earlier this month, I put up the schedule for the dates that FDA has scheduled for advisory committees for the year to give some limited as it provides a little insight into what can be expected in the way of approvals, though this year there were so many dates “TBD” that it may be a slightly more uncertain exercise than in years gone by.

In 2012, FDA approved 39 new drugs – the most in 16 years.  For this year, there are already a large number of meetings scheduled to consider new NDAs as well as some policy matters.  Here is an overview of what is to come for the rest of the first quarter 2013:

• January 29-30 – Pulmonary-Allergy Drugs Advisory Committee - On the 29th, meeting to discuss NDA for olodaterol (proposed name Striverdi Respimat) for proposed indication to treat COPD, sponsor Boehringer-Ingelheim.  On the 30th, the committee will meet to discuss NDA for mannitol inhalation powder (proposed name BRONCHITOL) for the management of cystic fibrosis.
• February 12 – Risk Communications Advisory Committee - The committee will meet to discuss a very interesting topic – general factors in risk communication about FDA approved products, including approaches to avoid message fatigue and related communications barriers such as prevention or warning fatigue or inaccurate risk perception.
• February 12 – Blood Products Advisory Committee – Meeting at Fishers Lane, this Blood Products AdComm will meet to discuss a BLA for proposed indication as a botulism antitoxin heptavalent (A, B, C, D, E, F) -(Equine), sponsor Cangene, seeking licensure under FDA’s authority to approve a product based on evidence of safety in humans and efficacy in animals when human efficacy studies are not feasible or ethical.
• February 14 – Medical Imaging Drugs Advisory Committee – This meeting will be to consider NDA for gadoterate meglumine injection (proposed tradename DOTAREM), sponsor Guerbet, LLC, proposed for use as MRI in the brain and spine to detect areas with disruption of the blood brain barrier and/or abnormal vascularity.
• February 22 – Neurological Devices Panel of the Medical Devices Advisory Committee – This committee will meet on the 22nd to discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System proposed as adjunctive therapy in reducing frequency of seizures in adults with partial onset of seizures from no more than two foci that are refractory to two or more anti-epileptic medications.
• March 4 – Reproductive Health Drugs Advisory Committee – The committee will meet to discuss 2 NDAs in one day – the first being for Depomed’s gabapentin 600 milligram tablets for the proposed indication for the treatment of moderate to severe vasomotor symptoms due to menopause; the second slated for the afternoon discussion will be to consider Noven Therapeutics’ NDA for paroxetine meylate 7.5 mg capsules also for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause.
• March 5 – Joint Meeting of the Reproductive Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee – The Committees will meet jointly to discuss whether the benefit of cacitronin salmon for the treatment of postmenopausal osteoporosis outweighs any risk.
• March 7 – Pulmonary-Allergy Drugs Advisory Committee – This meeting will be to consider another proposed COPD treatment.   Submitted by GlaxoSmithKline, the NDA for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREAO ELLIPTA) seeks approval for the treatment of airlfow obstruction and for reducing exacerbations in COPD patients.

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