A review published by the U.S. Food and Drug Administration (FDA) on April 10, 2015 indicates that Astra Zeneca’s key diabetes drugs-Onglyza (saxagliptin)-may be tied to “a significantly increased risk of all-cause mortality.”
Onglyza is a key AstraZeneca diabetes product that, in 2014, brought the drug maker sales of $820 million. AstraZeneca purchased the full rights to Onglyza in 2013 from a diabetes partnership it previously created with Bristol-Myers Squibb, according to Biopharmadive.com.
Our firm is pursuing class action lawsuits on behalf of individuals, or their loved ones, who suffered serious adverse reactions, including death, following treatment with Onglyza.
FDA Delays Onglyza Drug Combo
In October 2015, the FDA delayed AstraZeneca’s launch of a combination diabetes drug containing Onglyza and Farxiga (dapagliflozin). The agency indicated that it required more clinical trial data for the new combination drug.
Studies have suggested that Onglyza increases the risk of cardiac death. Farxiga is a SGLT-2, a class of drugs that has been under scrutiny for diabetic ketoacidosis, stroke, and cardiac problems.
AstraZeneca received a Complete Response Letter from the FDA asking for more detailed research and information. The company predicted in 2014 that the new combination drug could garner peak annual sales of $3 billion. In the first half of 2015, Onglyza sales generated $391 million and Farxiga reached $205 million.
Research Points to Potential Onglyza Cardiac Death
A prior study, entitled SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus), of more than 16,000 patients taking the blood sugar medication, Onglyza, revealed that they experienced a 27 percent increased risk of hospitalization due to heart failure when compared to the control group. An analysis conducted by the FDA revealed that the heart failure risk is valid, according to Reuters.
Although the overall trial results did not reveal a higher risk of death, a more in-depth analysis of the research involving only those patients who took Onglyza suggests “a significantly increased risk of all-cause mortality,” the review found.
While the FDA indicated that the causes of death were, in some cases, “multifactorial” and some study participants may have been diagnosed with serious medical conditions before their death, the FDA also noted that, it “is not reassured” by the increased risk, “and we do not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance,” according to Reuters.
Prior Agency Calls for Increased Research of Diabetes Medications
The FDA issued guidance in December 2008 that mandated drug manufacturers to conduct research that show that emerging diabetes drugs do not increase cardiovascular risks. The agency’s guidance followed mounting concerns regarding a number of diabetes medications.
FDA Convenes Meeting to Discuss Onglyza Risks
The FDA is convening an advisory committee the week of April 13, 2015 to discuss the implications revealed by the SAVOR study along with risks associated with, Nesina, a diabetes drug manufactured by Takeda Pharmaceutical Co. Onglyza received FDA approval in 2009; Nesina received FDA approval in 2013.
Should the meeting lead to a Black Box warning-the FDA’s most stringent warning-Onglyza sales may experience a significant dip in profits, Biopharmadive noted.
A Leerink analyst stated that the agency’s worries regarding all-cause mortality came as a surprise, Reuters wrote, and may lead to a reduction of up to 50 percent in the $1.8 billion Onglyza peak annual sales estimate, should competing drug, Januvia, not reveal similar issues.