April 10, 2015
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – AstraZeneca PLC’s diabetes drug Onglyza may cause an increased rate of death, a U.S. Food and Drug Administration panel said, Reuters reported Friday morning.
The FDA released a preliminary report today, ahead of a scheduled April 14 advisory committee meeting set to discuss the drug’s safety. Onglyza was approved in 2009.
The FDA began its investigation following a company-sponsored trial of more than 16,000 patients known as SAVOR showed 27 percent patients taking Onglyza, also known as saxagliptin, had an increased risk of hospitalizations due to heart failure, Reuters reported. The review found patients who took the drug incurred “a significantly increased risk of all-cause mortality.” The FDA said causes of death in the patients may have had numerous factors, including multiple medical conditions that played a role.’
In addition to AstraZeneca’s Onglyza, the FDA will also examine Takeda Pharmaceutical Co.’s Nesina. Both drugs are known as DPP-4 inhibitors. The FDA staff didn’t find an increase in deaths related to Nesina, according to the report.
The FDA said it was concerned by the increased risk. Additionally the FDA report said the panel did “not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.”
The FDA requested the new data following a study published in the “New England Journal of Medicine,” which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough due to use of saxagliptin.
In 2008 the FDA recommended manufacturers of Type 2 diabetes drugs provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The FDA said it was important to “better understand the safety of new antidiabetic drugs.”
Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack, the FDA said.
were slightly down this morning at $69.65 per share from the day’s high of $69.73.
In 2014 Onglyza generated $820 million in sales for AstraZeneca last year, while Nesina, which was approved in 2013, generated $403 million for Japan-based Takeda last year.
Another diabetes drug undergoing testing is Januvia, manufactured by Merck and Co., which brought in $3.93 billion in sales last year, according to Bloomberg.
More than 23 million people in the United States have been diagnosed with Type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia.
In addition to Onglyza AstraZeneca, working at the time with Bristol-Myers Squibb, manufactures Kombiglyze XR for the treatment of Type 2 diabetes in adults. The drug was approved by the FDA in 2010.
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After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
