AdComms for Last Quarter of 2014

It is hard to believe it, but we have entered the final quarter of 2014.  I thought it a good time to revisit the upcoming AdComm schedule for those AdComm meetings that affect drugs or devices. Prior postings that provided an overview by subject matter – as opposed to the chronological listing on the FDA site – seemed to have been useful for a number of readers. To see the full information provided by FDA, visit the FDA calendar page.

CARDIOVASCULAR

  • NDA Consideration Stroke Treatment On October 30, the Cardiovascular and Renal AdComm will meet to consider an NDA for edoxaban tablets being assessed for the prevention of storke and systemic embolism in patients with nonvavular atrial fibrillation.

CANCER

  • NDA – Mulitple Myeloma – A candidate treatment for multiple myeloma will be considered by the Oncology Drugs Advisory Committee on November 6.  The session is slated for the morning session and the proposed indication is for use in patients who have received at least 1 prior therapy and to be used  in combination with bortezomib and dexamethasone.
  • NDA – CKD – The NDA for ferric pyrophosphate solution for the treatment of iron loss or deficiancy in adult patients with hemodialysis-dependent stage 5 chronic kidney disesse an to reduce the prescribed dose of erythropoiesis stimulating agent required to maintain hemoglobin levels.

CYSTIC FIBROSIS

  • sNDA Consideration for ivacaftor Oral Tablets – On October 21, the Pulmonary-Allergy AdComm will meet to consider the sNDA for ivacaftor for the treatment of cystic fibrosis in patients 6 years and older with a R117H mutation in the cycstic fibrosis transmembrane conductance regulator gene.

GUIDANCE

  • Study Design – Oncoloytic Products – The Cellular, Tissue and Gene Therapies AdComm will be meeting on November 6 to discuss a draft guidance for industry – “Design and Analysis of Shedding Studies for Virus or Bacteria- Based Gene Therapy and Oncolytic Products” and the Dear Gene Therapy IND or Master File Sponsor Letter.

OPHTHALMOLOGY

  • Lens Consideration – The Ophthalmic Devices AdComm will meet on November 14 to discuss the premarket approval for an intraocular lens that combines the optical properties of a +3 diopter multifocal lens with the optical properties of a toric intraocular lens.  The proposed indication is for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a catactous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence.

PAIN

  • Device Consideration – On December 12, the Orthopaedic and Rehabilitation Devices AdComm will meet to discuss the premarket approval application for a device with the proposed indication to treat skelatally mature patients sufering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, withoor without Grade 1 spondylolisthesis, confirmed by X-Ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing.

PSORIASIS

  • BLA for secukinumab – The Dermatologic and Ophthalmic Drugs AdComm will meet on October 20  to consider the BLA for a monoclonal antibody fo rthe treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

SAFETY

  • Adverse Event Discussion – Chantix – On October 16, there will be a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee to discuss the safety data from observational studies and a meta-analysis of clinical trials since the original signal of neuropsychiatric adverse events associated with CHANTIX and whether any action needs to be taken.
  • REMS Examination – The Drug Safety and Risk Management AdComm will meet on November 18 to examine the REMS program for eculizumab (SOLIRIS) under the terms of the FDAAA which requires FDA to examine one or more REMS program at least annually to review a REMS program to ensure that it is not unduly burdensome on patient access to drugs and to minimize the burden on the health care delivery system.
  • Epidural Steroid InjectionsOn November 24, the Anesthetic and Analgesic AdComm will meet to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management and also consider the efficacy of ESI and te overall risk/benefit ratio.

Posting has been a challenge lately due to my schedule, but some good stuff coming up on social media and pharma.  Stay tuned.

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