Two years after a stinging rejection at the hands of the same committee, Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) got a warmer reception for their diabetes drug dapagliflozin, winning a recommendation from an FDA advisory panel and brightening their odds of approval for the once-rebuffed therapy.
The agency committee voted 13-1 that dapagliflozin's benefits outweighed its risks, and the group split 10-4 in favor of the drug's cardiovascular risk profile. That's welcome news for Bristol-Myers and AstraZeneca after the duo endured some skeptical glances from FDA reviewers who questioned whether instances of bladder cancer in dapagliflozin's pivotal studies should preclude approval of the treatment. The pair augmented their safety data for a second go at approval, and the results were enough to get advisers to change their thinking.
The drug is part of a new class of therapies that inhibit sodium-glucose transport proteins (SGLT2), spurring the body to ditch excess sugars through the urine and improving outcomes for patients with Type 2 diabetes.
Back in 2011, dapagliflozin flunked a meeting with the same panel on the way to an FDA rejection the following year, leading many to worry that the drug's misfortune would cast doubt on the whole class. But Johnson & Johnson ($JNJ) was able to get its SGLT2-blocking canagliflozin through the agency's rigors in March, giving hope to Astellas and partners Eli Lilly ($LLY) and Boehringer Ingelheim as they develop similar therapies.
J&J's gain is dapagliflozin's loss, of course, and the two-year delay did nothing but harm to the drug's potential market share. Bristol-Myers and AstraZeneca were once expected to rake in around $700 million a year from dapagliflozin at its peak, but that consensus has since slipped earthward to around $300 million, according to ISI's Mark Schoenebaum.
Still, the partners believe the new data that wooed advisers will be enough to sway the FDA, saying in a statement that they're "confident in the clinical development program that evaluated the safety and efficacy of dapagliflozin and that it provides substantial evidence to support its approval as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes."
Dapagliflozin is due for a final FDA ruling before Jan. 11. The drug is already on the market in Europe, where it sells as Forxiga.
- read the statement