After FDA snub, AZ diabetes combo faces potential years-long delay

Last year, AstraZeneca ($AZN) predicted its forthcoming diabetes combo med could generate peak annual sales of $3 billion. But those revenues will have to wait.

The FDA has turned down the drug, which combines AZ's DPP-4 therapy, Onglyza, with SGLT2 contender Farxiga. The company will need more clinical data from ongoing or completed studies to support its application, the agency said in a complete response letter, and regulators may want to see information from new studies, too.

"AstraZeneca will work closely with the FDA to determine the appropriate next steps and we remain committed to the development of the saxagliptin/ dapagliflozin fixed-dose combination," company spokeswoman Michele Meixell told FiercePharma in a statement.

While it's unclear how long the delay may last, it's a blow to the pharma giant. As Deutsche Bank analyst Richard Parkes told Reuters, the FDA rejection likely reflected a lack of data on the new formulation, rather than safety or efficacy worries, which could result in a launch holdup of between 12 and 24 months. Morgan Stanley analysts told the news service the med could roll out in 8 to 10 months in a best-case scenario, but that could extend to a few years if AZ needs new clinical trials, they said.

And that means it could be awhile before the med begins contributing to the $8 billion diabetes revenue haul the company last year predicted for 2023. On its own, Onglyza raked in $391 million in the first 6 months of this year, with Farxiga rounding up $205 million.

That Farxiga tally could be on the rise, though, if the drug can ride high on Eli Lilly ($LLY) and Boehringer Ingelheim's recently announced data showing that their SGLT2 challenger, Jardiance, cut the combined risk of heart attack, stroke and death from cardiovascular causes by 14% in high-risk Type 2 diabetes patients. Some analysts have predicted a "class effect," meaning Farxiga and Johnson & Johnson's ($JNJ) Invokana could benefit alongside Jardiance.

Meanwhile, another Lilly drug will be gaining from AZ's misfortune. The company's combo drug would have gone up against the Indianapolis drugmaker's Glyxambi, a med that now has "a clear run in the U.S.," Bloomberg Intelligence's Sam Fazeli told Bloomberg.

- read AZ's release
- get more from Reuters
- see Bloomberg's take

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