FDA Pharma Quarterly Review

Our staff has reviewed some of the most significant pharmaceutical review decisions by the FDA over the past quarter.  A number of interesting drugs are in the development pipeline for many companies, awaiting their fate from the FDA.

Approvals

• Genzyme receives FDA approval for a manufacturing plant for the production of Farazyme, a drug for the treatment Fabry disease.  Fabry disease is an enzyme-related lipid storage disease.
  Genzyme Gets Nod From FDA For Plant (FDA / Wall St. Journal)
  NINDS Fabry Disease (National Institute of Health)
• The kidney cancer drug axitinib by Pfizer was approved for used in treatment of advanced kidney cancer as a second-line treatment
  Pfizer Kidney Drug Gains FDA Approval (FDA / Wall St. Journal)
• Amlin Pharmaceutical's diabetes drug Bydureon was approved for once-weekly treatment for type-2 diabetes
  FDA Approves Amylin's Bydureon Diabetes Drug (FDA / Wall. St. Journal)
• A new drug approval for basal-cell carcinoma,  Erivedge (vismodegib), developed by Roche and marketed by Genentech Inc. paves the way for a new class of cancer drugs.  The new class of drugs known as "hedgehog drugs" targets cell communication pathways.  The entire course of treatment for the drug would average around t $75,000 per patients
  New Type of Cancer Drug Gets Approval (FDA / Wall St. Journal)
• Cystic Fibrosis drug Kalydeco by Vertex Pharmaceuticals was approved for first-line treatment of cystic fibrosis with a genetic mutation in the CFTR gene, affecting approximately 1200 people in the US.  Treatment with the drug is priced at $294,000 per year due to the small amount of patients and the high cost of development.
  FDA Approves Cystic Fibrosis Drug (FDA / Wall St. Journal)
• Two new suppliers of cancer drugs were approved by the FDA addressing an issue with shortages in the market due to a plant shutdown.
  Cancer-Drug Suppliers Approved (FDA / Wall St. Journal)

Denials and Warnings

• Dapagliflozin, an experimental diabetes drug as a part of a joint venture between AstraZeneca and Bristol-Myers Squibb was denied approval by the FDA
  Drug Setback for Bristol, Astra (FDA / Wall St Journal)
• Infinity Pharmaceuticals stopped development of hedgehog drug for pancreatic cancer after disappointing results.
  New Type of Cancer Drug Gets Approval (FDA / Wall St. Journal)
• The FDA issued a general warning on statins, requiring manufactures to add risks such as an increased risk of diabetes, high sugar levels, and memory loss.  The warning affects over a dozen different drugs in one of the most widely prescribed drug segments
  FDA Warns on Statin Drugs (FDA / Wall St. Journal)
• Merck was issued an FDA warning letter for failure to submit safety information for a rodent study in its diabetes drug Januvia and is required to resubmit a final study design within 30 days.
  Merck Gets FDA Warning Letter on Drug Study (FDA / Wall St. Journal)

Did we miss something or do you have any suggestions?  Let us know in the comments!

Photo Source: Food and Drug Administration