FDA Questions Safety of Anoro Ellipta

Dangerous drug lawyers at Pintas & Mullins Law Firm report that GlaxoSmithKline’s new drug for chronic obstructive pulmonary disease (COPD), Anoro Ellipta, revealed inconsistencies in safety during FDA reviews. The federal committee will soon vote on whether to recommend its approval.

The drug is a once-a-day treatment that uses 62.5 mcg of umeclidinium and 25 mcg of vilanterol for the long-term maintenance of COPD airflow obstruction, such as with emphysema and chronic bronchitis. The FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet tomorrow, September 10, 2013 to discuss the drug.

Vilanterol was approved this year and is already used in another GSK drug, Breo Ellipta, however umeclidinium is a new pharmaceutical not yet available on American markets. GSK does have a marketing application for umeclindinium currently pending as a stand-alone drug. In its safety profile, the FDA did note that there were some inconsistencies in certain safety signals for the combination drug.

Specifically, the agency highlighted an imbalance in the efficacy trials for nonfatal heart attacks, which was not noted in GSK’s year-long safety trial or its larger COPD safety database. There was also a notable difference in the safety/efficacy studies in patients being pulled from trials based on abnormal ECG and Holter readings (which monitor the electrical activity of the heart).

GSK conducted four six-month efficacy trials for Anoro Ellipta with 4,700 patients and one 12-month, placebo controlled safety study. Among its findings, the FDA confirmed that neither drug contributed more to the efficacy of the combination therapy. It also found that the drug improved COPD exacerbation and serial measurements of forced expiratory volume in one second (FEV1) in two active-controlled and two placebo-controlled trials.

In related news, at least two studies have been retracted which touted the benefits of heart medicine Diovan (valsartan) after it was discovered the data was altered. Novartis, the drugs’ manufacturer, denies any misconduct, however, it did confirm that the Japanese studies had conflicts of interest which it inappropriately did not disclose. Nevertheless, inaccuracies, distortions and investigations continue to emerge.

The scandal began in 2011 when an independent Japanese researcher illuminated an array of errors in publications authored by a Novartis employee, Nobuo Shirahashi, who took part in all five studies. One of the trials, the Kyoto Heart Study, was retracted in early 2013, prompting an investigation by Jikei University. Jikei found that study data regarding blood pressure had been intentionally altered during the analytical stage. Shirahashi was reportedly responsible for the data manipulation, though he has retired from Novartis and is uncooperative with investigators.

In light of this, at least eight Japanese hospitals have stopped prescribing Diovan, which was once considered a blockbuster drug to treat high blood pressure, heart failure, and cardiac arrest. It has been prescribed to millions of cardiovascular patients in the U.S. since the late 1990s, however, and the FDA has no plans to re-evaluate its safety or efficacy.

Another investigation by a Japanese university found that Diovan was not associated with any cardiovascular benefits, and that blood pressure data was again likely altered. Three other universities have opened investigations that are currently ongoing. The chairman of the Japanese Organization of Clinical Research Evaluation and Review stated that the scandal also illuminates the problems in the global race to create drugs that treat more than one condition. He said that drugs do not sell well if they are aimed only at one ailment, such as treating blood pressure; Novartis was under pressure to create a drug that was beneficial in preventing strokes and heart attacks in addition to high blood pressure.

Diovan lawyers at Pintas & Mullins Law Firm will continue to report on the Japanese investigations and other findings as they emerge. If you or a loved one was injured by an excessively dangerous, recalled, or contaminated drug, you have important legal rights, and may be entitled to compensation through a lawsuit against the manufacturer. Our attorneys offer free legal evaluations to injured patients in every state.


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