A new diabetes pill, dapagliflozin is effective but may cause bladder and breast cancer, says the FDA as it decides whether to approve the medication. This information was released today before a July 19th meeting by an Advisory Panel meeting in Silver Spring, Maryland.
Bristol-Myers Squibb Co. and AstraZeneca, who are working jointly on dapagliflozin, say they expect US regulatory authorities to come to a final decision on the drug’s submission for approval by the end of October 2011.
Clinical trials showed that there were more cases of breast and bladder cancers among the dapagliflozin patients than those on a placebo.
The trials revealed:
- 9 cases of bladder cancer among the dapagliflozin patients compared to 1 among the placebo ones
- 9 cases of breast cancer among the dapagliflozin versus 1 among the placebo ones
According to the FDA, dapagliflozin does not work so well in diabetes patients with impaired kidney function. The reviewers also mentioned liver injury, bone safety, and urinary and genital infections.
Ever since GSK’s (GlaxoSmitkline’s) blockbuster drug Avandia was linked to heart attack risk in 2007, the FDA and its equivalents around the world have been especially cautious about any existing and new diabetes pills. Avandia was eventually taken off the market in Europe and strictly controlled in the USA.
Reviewers in the FDA report wrote:
“Several unexpected safety issues identified in this clinical development program were of sufficient concern to FDA to merit discussion of their impact on the overall benefit-risk consideration of dapagliflozin.”
AstraZeneca, PLC, a British multinational drugmaker, is relying on a few key assets to compensate for a number of looming patent expiries, including Nexium and Seroquel. The FDA Advisory Panel’s recommendations next week may have an impact on the company’s outlook.
Some market experts predict that the FDA may ask for more evidence of dapagliflozin’s effectiveness before deciding on whether to approve it.
Written by Christian Nordqvist