As lawsuits move forward over Invokana, Johnson & Johnson’s Type 2 diabetes medication, the pharmaceutical giant’s subsidiary Jansen Pharmaceuticals, which manufactures the drug, hopes clinical trial results will be enough to earn it clearance later this year for use in treating diabetic patients’ heart problems. Invokana is a prescription medicine that is used along with diet and exercise to lower blood sugar. It is normally taken in combination with another drug, like Metformin or Glucophage, to decrease insulin resistance, because Invokana alone does not lower blood sugars enough to make it an effective single agent for the treatment of diabetes.
When the U.S. Food and Drug Administration (FDA) approved Invokana in 2013, it required Jansen to conduct a randomized controlled trial evaluating Invokana’s cardiovascular risks. Jansen launched that clinical trial seven years ago, called Canagliflozin Cardiovascular Assessment Study (CANVAS/CANVAS-R), which is expected to wrap up later this year, according to ThePharmaLetter. The trial includes as many as 10,000 patients living with Type 2 diabetes.
One part of the trial has measured the effect of Invokana on patients’ major adverse cardiovascular events including cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. Janssen hopes that the results will allow it to add an indication to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes, like Jardiance (another drug in the same class as Invokana).
The cardiovascular indication may be a pipe dream for Janssen. Invokana squeaked through the FDA approval process by an 8-7 vote. The FDA Advisory Committee was concerned that during the first month of clinical trials for Invokana, 13 participants receiving the drug had a heart attack or stroke, compared to only one in the placebo group.
Invokana has also been associated with a number of other serious side effects, including diabetic ketoacidosis (DKA). As you may know, DKA is a type of acidosis that develops when insulin levels are too low or during prolonged fasting that can lead to difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness. We wrote in a recent edition of this Report that from March of 2013, when the FDA approved it, to October of 2015, the agency received 101 reports of confirmable cases of acute kidney injury, some requiring hospitalization and dialysis. In approximately half of the cases, the acute kidney injury occurred within only one month of starting the drug.
In December, the Judicial Panel on Multidistrict Litigation consolidated 55 cases from across the U.S. into a multidistrict litigation (MDL). It also appointed U.S. District Judge Brian R. Martinotti to preside over the MDL that is pending in New Jersey federal court. The cases allege Jansen failed to properly test the Type 2 diabetes drug and warn of the risks and consequences of using it. As we mentioned in the February issue, Beasley Allen lawyer Danielle Mason was appointed to the Plaintiffs’ Steering Committee. She will help guide the process of pursuing justice for those suffering from J&J and Jansen’s failures.
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