Last July, some analysts felt that the FDA's adcomm on diabetes drugs dealt a mortal blow to the experimental dapagliflozin from Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) when a majority voted against an approval. Concerned by indications of an elevated risk of cancer as well as possible toxicity issues, the advisers felt there were better ways to treat diabetes. And their vote underscored a growing feeling in the development community that the odds for the regulatory game are stacked against new diabetes drugs.
But in a Bloomberg story, experts at the Cleveland Clinic are giving dapagliflozin a strong endorsement, indicating that the drug may be far from dead. A few weeks ago the Cleveland Clinic listed dapagliflozin as a top potential game-changer in the medical world. And that could prove encouraging for a lineup of development programs for other drugs in the same class.
Steve Nissen, who heads cardiovascular medicine at the Cleveland Clinic, told Bloomberg that dapagliflozin is a "potentially important addition" to treatment options. "My guess is that within the next year, this will get over the goal line. This is as good as anything we've seen."
The cancer risk? Nissen isn't convinced there is one, primarily because the sudden appearance of a handful of tumors indicated that they had already been developing before treatment began. "Nobody thinks this signal seen on breast cancer is real," Nissen said. "The bladder cancer signal may simply represent a certainment bias. Obviously, the issue will need ongoing surveillance, but it may turn out to be a false signal."
Whether that's an argument that will wash with the FDA, though, won't be known for another three months. Last week the agency announced that it was delaying its final decision on dapagliflozin, a treatment worth potentially more than $600 million a year, by three months.
Last July Goldman Sachs analyst Jami Rubin considered the majority vote against dapagliflozin a black mark for an entire slate of SGLT2 inhibitors. Johnson & Johnson ($JNJ), Pfizer ($PFE), a Lilly and Boehringer partnership, Lexicon, Isis and others have their own SGLT2 inhibitors in development.
- here's the article from Bloomberg