Onglyza, Kombiglyze Maintain Risks in Spite of Dismissed Lawsuits

July 22, 2017, 12:00PM. By Gordon Gibb

Trenton, NJPlaintiffs bringing either a saxagliptin lawsuit, or an Onglyza lawsuit (Onglyza is the trade name for saxagliptin) appear to have had a checkered track record in terms of success with their cases in spite of various side effects associated with the Type 2 diabetes drug.

According to the Form 20-F filing issued by Onglyza manufacturer AstraZeneca PLC to the US Securities and Exchange Commission for its fiscal year ending December 31st of last year, the claims of 14 plaintiffs were dismissed. Those plaintiffs alleged heart failure, cardiac failure and/or death from treatment with either Onglyza, or alleged to be suffering from Kombiglyze side effects. The cases were dismissed in response to motions filed by AstraZeneca in spite of associated impacts to the heart if not outright causing heart attacks. It should be noted that Kombiglyze XR is saxagliptin and metformin HCl combined, designed for extended-release and approved by the US Food and Drug Administration (FDA) in 2010. Onglyza was approved the year prior.

In May of last year, a federal judge in California granted AstraZeneca’s motion for summary judgment and dismissed the claims of 14 plaintiffs who alleged pancreatic injuries, including pancreatic cancer, from treatment with either Onglyza or Kombiglyze.

This, in spite of a mandate by the FDA to have information about pancreatitis added to the warnings and precautions for Onglyza and other drugs in the DPP-4 and GLP-1 class.

The reasoning behind the requests for summary judgment and the dismissal of the cases was not made clear. However, AstraZeneca is motivated to protect Onglyza and Kombiglyze given the growth of the drugs in the marketplace. According to drugwatch, Onglyza and Kombiglyze reached sales of $786 million in 2015 – five years after approval – with analysts predicting that revenue could mushroom to $2.47 billion in annual sales by next year, provided the drug continues to track along a similar path.

There are risks and side effects associated with the drugs. Onglyza side effects (and Kombiglyze side effects) include saxagliptin heart attack (among others,) although there is a caveat with the drug’s risk to the heart.

Saxagliptin has not been found to contribute directly to heart attacks. However, researchers did not find any evidence that Onglyza could protect the heart, either. What’s more, researchers found a 27 percent increased risk of hospitalization for heart failure and a potential increased risk for “all-cause mortality,” according to statistics posted at drugwatch.

The FDA, for its part reviewed the results of two large clinical trials in 2013: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus–Thrombolysis in Myocardial Infarction 53, a study known as SAVOR-TIMI 53, and Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE).

The SAVOR study, with 16,492 participants, found a possible link between Onglyza and an increase in heart failure. EXAMINE, on the other hand, included 5,380 study participants 3.9 percent of whom were hospitalized for heart failure versus 3.3 percent receiving placebo.

The editor in chief of the Journal of the American College of Cardiology, Dr. Anthony DeMaria, said in comments to Reuters that those at risk for heart failure should probably avoid Onglyza.

The dismissal of the saxagliptin heart attack and Onglyza side effects lawsuits involving heart and pancreatic cancer issues from 2016 has not discouraged others from filing Kombiglyze side effects lawsuits. Plaintiff Earl Binns filed his lawsuit this past May claiming that he developed coronary heart disease and congestive heart failure as a result of taking saxagliptin.

The case is Earl Binns v. Bristol-Myers Squibb Company et al, Case No. 3:17-cv-03028, US District Court, District of New Jersey. Amylin Pharmaceuticals LLC and AstraZeneca PLC have also been named as defendants in various lawsuits.