FDA Panel Wants Heart Risk Warnings for AstraZeneca PLC, Takeda Diabetes Drugs
April 15, 2015
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Federal regulators said AstraZeneca PLC ’s diabetes drug Onglyza should carry a label notifying users of the risks of heart failure, but added the risk is acceptable, the agency said in a statement Wednesday.
A U.S. Food and Drug Administration (FDA) panel met Tuesday to discuss the drug’s safety, as well as the safety of Takeda Pharmaceuticals ’s Nesina, also used to treat diabetes, both of which belong to a drug class known as DPP-4 inhibitors. The FDA panel found neither Onglyza nor Nesina increased the risk of cardiovascular death, stroke or heart attack. 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.
An AstraZeneca-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. The FDA analysis didn’t find a reason for the higher number of people on Onglyza who died, compared with the placebo, Bloomberg reported.
The FDA said causes of death in the patients may have had numerous factors, including multiple medical conditions that played a role. Data shows there is a statistically significant increase in the risk of heart failure with Onglyza and an increased risk with Nesina that did not reach statistical significance, Reuters reported. FDA panelists said the risk of heart failure with Nesina was not the same as Onglyza, the regulators felt it should also include the warning label. The panelists suggested the risks may be associated with the DPP-4 class of drugs, Reuters reported.
The FDA panel voted 13-1, with an abstention, that Onglyza’s cardiovascular risk was acceptable and 16-0 that Nesina’s risk is also acceptable, according to multiple news reports. The panel did not recommend any restrictions on prescribing Onglyza or Nesina.
AstraZeneca’s (ASN) stock was trading up following the news, with a morning high of $72.18 per share. Takeda (TKPHF) was also trending up, with a high of $50.58 per share.
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 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 anti-diabetic 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 anti-diabetic 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 anti-diabetic therapies put patients at increased risk of heart attack, the FDA said.
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.
In addition to Onglyza and Nesina, Merck & Co. also has a DPP-4 drug called Januvia, while Eli Lilly and Company and Boehringer Ingelheim have teamed to manufacture Tradjenta.
DPP-4 inhibitors cause the body to produce more insulin after eating, which reduces glucose levels. Merck will release its own heart-risk study for Januvia patients in June. Januvia generated $3.93 billion in sales last year. An analyst told the Associated Press if Merck’s drug does not require the warning labels, then Januvia could “cut sales of AstraZeneca's diabetes drugs by 50 percent.”
BioSpace Temperature Poll
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?