FDA Links Onglyza to Possible Increased Risk of Death
AstraZeneca’s diabetes drug Onglyza may be linked to a higher death rate, according to the U.S. Food and Drug Administration.
This finding came from a preliminary FDA review and was posted on the agency’s website ahead of a key panel meeting.
Upcoming FDA Panel Meeting on Onglyza and Nesina
An FDA advisory panel will meet on April 14 to evaluate the safety of Onglyza and a similar drug, Nesina.
Onglyza was approved in the United States in 2009.
Nesina, developed by Takeda Pharmaceutical Co, received approval in 2013.
SAVOR Trial Shows Heart Failure Risk with Onglyza
A major trial known as SAVOR included more than 16,000 patients who took Onglyza, also called saxagliptin.
The trial showed an increased risk of hospitalization due to heart failure for patients taking Onglyza.
The FDA validated the heart failure concern and also flagged a potential increased risk of death from all causes.
Detailed Analysis Points to All-Cause Mortality Concerns
Initial trial results did not show a clear increase in death risk.
However, deeper analysis of Onglyza users suggested a “significantly increased risk of all-cause mortality.”
The FDA noted that many deaths were “multifactorial” and patients often had serious existing health problems.
Still, the FDA stated it “is not reassured” and does not believe this death pattern is due to chance.
Nesina Shows No Similar Safety Signal
The FDA reviewed another drug in the same class, Nesina (alogliptin), but found no similar death or heart failure concerns.
A large study called EXAMINE showed nearly identical results between Nesina users and placebo recipients.
There was no statistically significant increase in heart failure risk associated with Nesina.
Merck’s Januvia Trial Results Still Pending
Medical professionals and investors are awaiting results from a heart safety trial involving Merck’s Januvia, a DPP-4 inhibitor like Onglyza.
Januvia generates $4 billion in yearly sales and is the leading drug in its class.
Results from Merck’s trial are expected to be released in June.
Sales Forecast Impact and Analyst Concerns
Analyst Seamus Fernandez of Leerink called the FDA’s mortality concern unexpected.
He warned that Onglyza’s peak annual sales estimate could be cut by 50 percent.
This estimate drop depends on whether Januvia shows similar safety problems.
FDA Cardiovascular Guidance Background
In December 2008, the FDA began requiring drugmakers to prove that new diabetes drugs do not raise heart disease risks.
This guidance was issued due to rising concerns over cardiovascular safety in diabetes medications.
AstraZeneca Responds to FDA Report
AstraZeneca said the SAVOR trial met its main goal: showing no increased risk of serious cardiovascular events.
That includes cardiovascular death, non-fatal heart attacks, and non-fatal ischemic strokes.
AstraZeneca added it would work closely with the FDA to support continued review of the trial data.
Company shares dropped 0.2 percent, recovering from earlier losses.
Merck’s shares fell 0.6 percent following the FDA’s statement.
(Additional reporting by Ben Hirschler in London and Bill Berkrot in New York; Editing by Susan Heavey and Dan Grebler)
Source: AOL
