New FDA Warning Impacts Diabetes Drugs Made by AstraZeneca PLC, Johnson & Johnson and Eli Lilly
May 18, 2015
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) is investigating diabetes drugs used to treat Type 2 diabetes made by Johnson & Johnson , AstraZeneca PLC and Eli Lilly and Company after 20 cases of ketoacidosis which required hospitalization were reported.
Federal regulators fired off a warning Friday that sodium-glucose cotransporter-2 (SGLT2) inhibitors used to treat type 2 diabetes may lead to diabetic ketoacidosis requiring hospitalization. The FDA warning will have implications on Invokana, manufactured by Johnson & Johnson, dapagliflozin, also known as Farxiga, and combination drug Xigduo XR, dapagliflozin/metformin, both developed by AstraZeneca, empagliflozin, or Jardiance, and Glyxambi, both made by Eli Lilly and Germany-based Boehringer Ingelheim.
The FDA said a search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. Each of the patients required hospitalization or emergency room treatments. The FDA said it has received additional reports of patients requiring hospitalization since June of 2014, but it did not specify how many.
Boehringer last year was forced to commit nearly $500 million to fix its empagliflozin plant in Germany after the FDA noted manufacturing deficiencies that caused the federal regulator to initially reject the drug. The drug was approved later in the year after the issues were addressed.
In its warning on Friday, the FDA said the SGLT2 inhibitors may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. Diabetic ketoacidosis most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels, the FDA said.
Although it encouraged people prescribed these medications to continue taking them as directed by doctors, the FDA warned that patients taking these SGLT2 inhibitors should monitor themselves for any signs of ketoacidosis and “seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.”
If the FDA investigation results in new warning labels, it could cause the companies to take a financial hit.
In its report on the FDA warning Bidnessetc noted Invokana, along with its combination diabetes drug Invokamet, generated almost $278 million in sales during the first quarter of 2015, a big jump over the previous year. Neither AstraZeneca nor Eli Lilly have posted sales figures from their SGLT2 inhibitors, however AstraZeneca reported Farxiga “captured one in all of three SGLT2 prescriptions, helping to boost the sales of the whole class by 115 percent,”
Type 2 diabetes affects 90 to 95 percent of the 26 million Americans diagnosed with diabetes. People with type 2 diabetes typically cannot make, or use the insulin their body produces, which allows glucose to enter the body’s cells, causing the cells to not act as designed. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
In trading this morning AstraZeneca’s stock was down slightly to $68.72 per share from its opening of $68.80 per share. Eli Lilly’s stock was also down at $72.88 per share from a morning high of $73.05. Johnson & Johnson’s stock’s stock was up to $103.03 from its open of $102.32.
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