Thursday, January 19, 2012

Dapagliflozin diabetes drug

  • TRENTON, N.J. -- In a setback that could spell trouble for several drugmakers developing a new type of diabetes pill, U.S. regulators have told partners Bristol-Myers Squibb Co.
  • (Huffington Post)
  • The two companies said on Thursday they had received a so-called complete response letter from the Food and Drug Administration (FDA) for dapagliflozin as a treatment for type 2 diabetes in adults.
  • (msnbc.com)
  • The Food and Drug Administration is seeking data from ongoing studies of the treatment, dapagliflozin, in adults with Type 2 diabetes and may require new clinical trials to better assess the risks and benefits, the companies said today in a statement.
  • (Businessweek)
  • Dapagliflozin has been shown in studies to help patients lose weight and lower blood pressure. Older diabetes drugs either reduce blood-sugar levels or increase production of insulin, a hormone needed to convert sugar into energy.
  • (Bloomberg)
  • The companies said they remain committed to the drugs development, and will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application.
  • (Marketwatch)
  • AstraZeneca slipped 41.5p to £30.70 after US regulators said they needed more clinical data before approving its new diabetes drug dapagliflozin, developed with Bristol-Myers Squibb.
  • (The Guardian)

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