Bristol-Myers Squibb’s SGLT-2 diabetes medication dapagliflozin, known as Forxiga abroad, is up for another FDA panel review Thursday. Last year’s fallout included a Complete Response Letter and a back-and-forth between Bristol-Myers and partner AstraZeneca and the regulator, in which the drugmakers tried to make a case for why they should not have to provide additional information, and failed.
A redacted version of the January 17, 2012, CRL is online, but the available text highlights then-regulator concern regarding cardiovascular risk, breast cancer, bladder cancer and liver safety.
The latest review documents indicate the advisory panel is not wholly mollified by the new data that accompanies the submission.
Bladder cancer looks like a possible sticking point. The briefing document says the bladder cancer risk is not a favorable one, and that a similar situation was not seen in Johnson & Johnson’s Invokana (canagliflozin), which the FDA approved in March. This concern does not mean another thumbs-down from the panel: in his Tuesday research note Leerink Swann analyst Seamus Fernandez honed in on the fact that the regulator’s brief notes that bladder cancer concerns should probably trigger additional study and “possibly labeled as a precaution or warning for its safe use if approved.”
As for breast cancer, Fernandez’s takeaway was that “compelling evidence appears to have been offered that largely washed out the original breast cancer signal,” while the briefing document notes that the previous breast cancer incident data may be “spurious” because patients were not screened for breast cancer before the study and the detection occurred a year after taking dapagliflozin.
The briefing documents indicate that the drugmakers may be on comfortable ground in terms of liver risk and that the drug meets cardiovascular risk requirements.
ISI Group analyst Mark Schoenebaum noted in his Tuesday assessment that the drug has low expectations—$300 million in peak US sales—and that the company’s immuno-oncology focus is Bristol-Myers’s bedrock, which is in-line with the company’s November announcement that it was walking away from diabetes, hepatitis and neuroscience.
