FDA rejects AstraZeneca's diabetes combo and demands more data

AstraZeneca's headquarters in London--Courtesy of AstraZeneca

The FDA wants to see more clinical trial data on AstraZeneca's ($AZN) new combination diabetes treatment, the company said, likely delaying a potential launch by more than a year.

AstraZeneca's combo is a fixed-dose mix of saxagliptin, approved as Onglyza, and dapagliflozin, sold as Farxiga, designed to treat Type 2 diabetes. In its rejection letter, the FDA asked for additional data on the cocktail, a request that "may require information from new studies," AstraZeneca said. The company has pegged $3 billion in peak annual sales to the combination, a forecast now imperiled by regulatory delay.

Saxagliptin works by blocking a protein called DPP-4 to reduce blood glucose, while dapagliflozin targets SGLT2 to divert excess sugar out through the urine. Each faces a crowded monotherapy market, with contenders from Merck ($MRK) and Johnson & Johnson ($JNJ) leading the way, and partners Eli Lilly ($LLY) and Boehringer Ingelheim won the first-ever approval for an SGLT2/DPP-4 combination in February with a treatment called Glyxambi.

The combo's rejection is unlikely to affect its individual parts, AstraZeneca said. It's unclear whether the FDA's hesitation is related to recent safety concerns tied to Onglyza, whose cardiovascular risks led a panel of agency advisers to recommend updating its label to include a warning about its potential to increase the odds of heart failure.

AstraZeneca's diabetes pipeline is particularly crucial to the company's long-term strategy. In 2014, while trying to shake off Pfizer's ($PFE) buyout interest, the U.K. drugmaker promised to deliver annual revenue above $45 billion by 2023, with $8 billion of that sum coming from its diabetes portfolio.

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