Forxiga received a positive opinion from the European Medicines Agency's (EMA) Committee on Medicinal Products for Human Use (CHMP) on 19 April 2012, but as Nature Biotechnology went to press, the drug still had not received formal European Commission (EC) approval. This usually follows automatically after 67 days. AstraZeneca officials were tight-lipped on the issue and declined an interview request. “Although we cannot speculate about the precise timing of a final decision from the EC, our best judgment is that a final EC decision will occur in [the second half of 2012],” company spokeswoman Kirsten Evraire states in an e-mail.
The CHMP's positive assessment of Forxiga diverged from that of the FDA, which issued a complete response letter on 19 January 2012, citing a need for more clinical information on the drug's risk-benefit profile and, possibly, additional trials. What the FDA called “a numeric imbalance” in the frequency of breast and bladder cancers emerged in the Forxiga development program, although the trial was not powered to detect whether this represented an actual risk. “I suspect this is a non-issue, and it certainly was thought to be a non-issue by the EMA,” says Anthony Barnett, emeritus professor of medicine at Birmingham Heartlands Hospital in Birmingham, UK. Assuming rival drugs raise no such concerns—and none has been reported as yet—Forxiga is, nevertheless, unlikely to attain blockbuster status, according to Flamme. “In that respect, we believe it is dead,” he says. Moreover, the companies may not even pursue approval in the US, if the FDA requires additional trials. “I think it would be too costly, so I'm not sure they would do it.”
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