- A new review of data published by the FDA on Friday harbors some bad news for AstraZeneca: One of the company's key diabetes products, the blood sugar medication Onglyza, appears to be associated with "a significantly increased risk of all-cause mortality." A 16,000 patient study showed Onglyza patients had a 27% higher chance of being hospitalized with heart failure versus the control.
- Onglyza is one of AZ's main diabetes products and brought in sales of $820 million in 2014. The company bought the full rights to the drug in 2013 from a diabetes partnership that it had formed with Bristol-Myers Squibb.
- The FDA will convene an advisory committee to discuss the study's implications, as well as the risks of another diabetes drug from Takeda, on Tuesday. If that meeting eventually leads to a black box warning for Onglyza, sales could dip dramatically as physicians switch their patients to other diabetes meds.
As this new analysis demonstrates, the contours of a drug's safety profile don't always fully reveal themselves during the clinical trial process.
FDA officials said that the data, while mixed in the sense that Onglyza patient deaths stemmed from multiple factors including serious medical conditions in the days and weeks before death, were still cause for concern. The agency said it "is not reassured that the observation that causes of death span multiple disparate etiologies, and we do not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance."
In other words, AstraZeneca may have some trouble on its hands.
UPDATE: AstraZeneca has responded to the situation, saying that it stands by Onglyza's safety profile and that the company will "work closely with the FDA to support further review of the data."
The incident, alongside the Takeda blood sugar drug review, has raised questions over the safety of so-called DPP-4 inhibitor diabetes meds. Another major drug in this category is Merck's Januvia. And in the type of prediction that could have Sanofi brass sweating, one analyst said he could see Onglyza sales plummet in half if Januvia proves to still be safe.