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AbbVie Inc. 34 articles

Testosterone makers in tit-for-tat with insurance company

Medical Mutual of Ohio (MMO) filed a motion in Illinois federal court to compel drug companies AbbVie Inc. and Eli Lilly & Co., to produce documents in a putative class action over allegedly fraudulently marketing involving their testosterone replacement therapies. AbbVie and Lilly lashed back arguing that the insurance company had filed the motion prematurely without first trying to handle the dispute out of court. AbbVie said that had MMO done so, then it would have learned that AbbVie was planning to provide more information, which is more than MMO has done during the discovery process. The tit-for-tat stems from ... Read More

Testosterone replacement therapy seen in ‘negative shade of light’

The global market for testosterone replacement therapy is expected to reach a value of $1.3 billion by the end of 2024, according to market research group Transparency Market Research, a value lower than the previous year of $2 billion. As a result, the market will show a negative compounding annual growth rate of -4.2 percent over the course of the forecast period of 2016 to 2014, the report finds. This is despite a growing population of men who suffer from testosterone deficiency between the age of 40 to 79. Testosterone replacement therapy, such as AbbVie’s AndroGel, is used to treat ... Read More

Man blames AndroGel for his heart attack

Attorneys for a man suing AbbVie Inc., maker of AndroGel, told an Illinois federal jury that the drug company never tested its testosterone replacement therapy to rule out if it could cause heart problems, Law360 reported. Otherwise plaintiff Jeffrey Konrad would never have taken the drug, they said. Konrad’s case is the second bellwether trial in a multidistrict litigation (MDL) taking aim at testosterone manufacturers. AbbVie, as the maker of the top selling AndroGel, is the first drug maker to sit in the hot seat. The first trial against AbbVie ended in a $150 million in punitive damages for the ... Read More

Two deaths reported in trial of new RA drug

Drug company AbbVie Inc., touted promising clinical trial results with its potential best-in-class rheumatoid arthritis treatment, but two patient deaths cast a dark shadow over the news, BioPharma Dive reported. The experimental drug ABT-494, known chemically as upadacitinib, is in a class of medications called Janus kinase (JAK) inhibitors. The drug is designed for patients with moderate-to-severe rheumatoid arthritis, or RA, who are not adequately treated by the standard biologics. The phase 3 SELECT-BEYOND clinical trial tested the drug at both 15mg and 30mg doses, and its primary endpoint of reducing the symptoms of RA by 20 percent over 12 ... Read More

AndroGel marketing materials cannot be barred from next trial

AbbVie Inc., failed to convince an Illinois federal judge to block jurors from seeing its marketing materials for its testosterone replacement therapy AndroGel in the next bellwether trial in a mulstidistrict litigation (MDL), according to Law360. The drug company’s aggressive marketing practices were the damning evidence in the first testosterone side effects trial to reach verdict in the MDL, costing AbbVie $150 million in punitive damages to a couple who sued the company over cardiovascular risks. U.S. District Judge Matthew F. Kennelly denied AbbVie’s motion for reconsideration on his ruling and punished the company by docking 30 minutes of trial ... Read More

Verdict reached in first testosterone state case

Pharmaceutical company AbbVie Inc. scored a win in Illinois state court over claims that the company’s testosterone replacement therapy AndroGel caused a man’s heart attack, according to Law360. The news come just weeks after an Oregon couple was awarded $150 million in a similar case involving AndroGel in an Illinois federal court. James Couch sued AbbVie alleging the drug maker failed to warn him or his doctor that using AndroGel could cause cardiovascular risks including life-threatening heart attacks, strokes and blood clots. Couch’s lawsuit is one of about 150 in Cook County, Illinois state court involving testosterone side effects. Couch claimed strict ... Read More

$150M verdict sends message to testosterone makers

The Illinois jury that awarded an Oregon couple $150 million in a case alleging AbbVie Inc.’s testosterone replacement therapy AndroGel caused his heart attack sent a loud-and-clear message to drug companies: Lay off the heavy advertising. Jesse Mitchell and his wife Kimberly filed their lawsuit in November 2014. It became one of more than 7,000 lawsuits against AbbVie and other manufacturers of testosterone replacement therapies alleging the drug caused heart attacks, strokes and blood clots. The lawsuits were consolidated into a multidistrict litigation (MDL) in the Northern District of Illinois in 2014. Mitchell’s case was the first bellwether trial in ... Read More

Axiron safety label updated

The Patient Counseling Information/Patient Information/Medication Guide for the topical testosterone gel Axiron has been updated to include clarifications such as ensuring patients know how to administer the correct dosage as well as understanding that they should not drink the product. Axiron is a testosterone supplement intended for men with low levels of the male hormone due to injury or disease. It is a topical gel that is applied to the armpits. Patients are advised to wash their hands right away with soap and water after applying the gel and, once the solution has dried, to cover the area with clothing to ... Read More

Testosterone heart risk not worth benefit

Jesse Mitchell was in his mid 40s when he was stricken with lethargy, anxiousness and depression. He started taking AndroGel testosterone replacement therapy, lured by the aggressive marketing campaigns geared directly to consumers informing them that AndroGel could cure so-called Low T. Mitchell said the gel did boost his energy and he continued to use the hormone treatment, Law360 reported. But in 2012, after using the medication for about two years off and on, Mitchell suffered a heart attack. He learned that testosterone treatments had been linked to cardiovascular risks including heart attacks, strokes, blood clots and death, and in ... Read More

Former FDA chief calls AndroGel ads misleading

AbbVie Inc. misled the public by aggressively promoting its testosterone replacement therapy AndroGel for off-label uses, said the former commissioner of the Food and Drug Administration (FDA). The statement was part of expert testimony in a case of a man alleging AndroGel caused him to suffer a massive heart attack, Law360 reports. David Kessler, who served as FDA commissioner from 1990 to 1997, said that AbbVie promoted its testosterone gel directly to men by fabricating a condition called “Low T” to treat symptoms such as low libido, weight gain and muscle loss. AbbVie understood that those symptoms, as well as ... Read More