Invokana Renal Study Stopped Early
The Janssen Pharmaceutical Companies of Johnson & Johnson has ended the phase 3 Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation, also known as CREDENCE. The company did not reveal the reason nor the results of the study.
Type 2 diabetes is a medical condition affecting over 9% of the population or an estimated 28 million Americans. The most common drug to treat Type 2 diabetes is Invokana. Manufactured by Johnson & Johnson, Invokana is the brand name of the drug canagliflozin, which is a sodium glucose cotransporter-2 (SGLT2) inhibitor. This class of Type 2 diabetes drugs lowers blood sugar by causing the kidneys to remove sugar from the body via urine.
In March 2013, the FDA approved the drug, however by May 2015 they were warning that this drug may lead to devastating side effects like kidney and bladder cancer.
Janssen Invokana Renal Study
The purpose of the study was to assess whether Invokana could possibly cause renal cancer. Nearly half of all people with Type 2 Diabetes develop chronic kidney disease that could lead to cancer. This study followed people with type 2 diabetes mellitus, stage 2 or 3 CKD and macroalbuminuria.
The trial enrolled approximately 4,400 patients with type 2 diabetes mellitus. All patients ingested maximum labeled or dose of Invokana for more than four weeks prior to the random study. Janssen estimated the duration of the study to be about 5 to 5.5 years, however, it only lasted four.
Speculation points to boost third-quarter earnings. Invokana sales are down 27% this year. This equates to a $215 million loss in the period from April to June. While Invokana was the first SGLT-2 inhibitor to enter the market in 2013, it now faces multiple rivals from the same class. Invokana is still the class leader by sales, but revenues have been on a downward trend for several quarters. This comes as more people come forward citing damages from the medication.
Mounting Invokana Lawsuits
Hundreds have already filed a lawsuit with Invokana manufacturer, Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson. Plaintiffs are accusing the manufacturer of failing to warn health professionals and patients of the drug’s risks.
Over 450 serious adverse events reported to the FDA between March 2013 and March 2014, as documented by the Institute for Safe Medication Practices found this rate to be higher than 92% of other medicines regularly checked. The report notes the “clear evidence of harm” Invokana reaches the kidneys.
When a clear evidence of harm exists, you deserve to be compensated.
Invokana manufacturer, Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has netted almost $1 billion in profits from Invokana in the last year alone. Meanwhile, the number of individuals injured by Invokana have begun to accumulate. They have begun to file consumer protection lawsuits against the pharmaceutical giant.
At the present time, The Michael Brady Lynch Firm is concentrating on Pennsylvania. This is the location where our cases are pending against the makers of Invokana. This will most likely mean a mass tort consolidation at the Federal level is imminent. Let our decades of experience bring you justice.