theadanews.com - Ada, Oklahoma

Community News Network

March 5, 2014

Lilly's diabetes drug rejected by FDA

NEW YORK — A diabetes pill developed by Eli Lilly and Boehringer Ingelheim was rejected by U.S. regulators because of previously disclosed manufacturing deficiencies at a German plant that hadn't been resolved.

The Food and Drug Administration inspected Boehringer's Ingelheim am Rhein facility in 2012 and warned the Ingelheim- based company of the faults in May 2013. No new clinical studies will be needed to approved the drug, called empagliflozin, the companies said Wednesday in a statement.

"The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured," the companies said. The FDA won't approved the drug until the problems are fixed.

About 24 million people in the United States have diabetes, a condition often driven by obesity where the body loses its ability to process sugar.

Empagliflozin is part of a class of drugs that includes Johnson & Johnson's Invokana and AstraZeneca's Forxiga. The drugs help the body get rid of sugar through the kidneys.

The Lilly-Boehringer drug is projected to sell $295 million for Lilly in 2019, according to analyst estimates compiled by Bloomberg.

The FDA re-inspection of Boehringer's plant is continuing, said Emily Baier, a spokeswoman for the company. "The inspection is reviewing aspects related to production, processes, quality assurance and other related areas," said in an email. It could take up to six months after the inspection for the FDA to decide whether the problems have been fixed.

The 2012 inspection found what the FDA called "significant violations of current manufacturing practice" at the plant. They included a failure to look into issues with the active ingredients of drug made there as well as contamination problems that also weren't investigated.

The warning letter last year didn't specifically mention empagliflozin, Philip Johnson, Lilly's vice president of investor relations, said on a Jan. 7 conference call.

"Empagliflozin was not specifically cited in that warning letter," Johnson said. "There was other commercial production that was specifically referenced. Boehringer Ingelheim has been working through this with the FDA."



 

1
Text Only | Photo Reprints
Community News Network
  • Sunburn isn't the only sign of summer that can leave you itchy and blistered

    You've got a rash. You quickly rule out the usual suspects: You haven't been gardening or hiking or even picnicking, so it's probably not a plant irritant such as poison ivy or wild parsnip; likewise, it's probably not chiggers or ticks carrying Lyme disease; and you haven't been swimming in a pond, which can harbor the parasite that causes swimmer's itch.

    July 30, 2014

  • Survey results in legislation to battle sexual assault on campus

    Missouri U.S. Sen. Claire McCaskill joined a bipartisan group of senators Wednesday to announce legislation that aims to reduce the number of sexual assaults on college campuses.

    July 30, 2014

  • An alarming threat to airlines that no one's talking about

    It's been an abysmal year for the flying public. Planes have crashed in bad weather, disappeared over the Indian Ocean and tragically crossed paths with anti-aircraft missiles over Ukraine.

    July 30, 2014

  • Sharknado.jpg Sharknado 2 set to attack viewers tonight

    In the face of another "Sharknado" TV movie (the even-more-inane "Sharknado 2: The Second One," premiering Wednesday night on Syfy), there isn't much for a critic to say except to echo what the characters themselves so frequently scream when confronted by a great white shark spinning toward them in a funnel cloud:
    "LOOK OUT!!"

    July 30, 2014 1 Photo

  • 20140729-AMX-GIVHAN292.jpg Spanx stretches into new territory with jeans, but promised magic is elusive

    The Spanx empire of stomach-flattening, thigh-slimming, jiggle-reducing foundation garments has expanded to include what the brand promises is the mother of all body-shaping miracles: Spanx jeans.

    July 29, 2014 1 Photo

  • Medical marijuana opponents' most powerful argument is at odds with a mountain of research

    Opponents of marijuana legalization are rapidly losing the battle for hearts and minds. Simply put, the public understands that however you measure the consequences of marijuana use, the drug is significantly less harmful to users and society than tobacco or alcohol.

    July 29, 2014

  • linda-ronstadt.jpg Obama had crush on First Lady of Rock

    Linda Ronstadt remained composed as she walked up to claim her National Medal of Arts at a White House ceremony Monday afternoon.

    July 29, 2014 1 Photo

  • Can black women have it all?

    In a powerful new essay for the National Journal, my friend Michel Martin makes a compelling case for why we need to continue the having-it-all conversation.

    July 29, 2014

  • Dangerous Darkies Logo.png Redskins not the only nickname to cause a stir

    Daniel Snyder has come under fire for refusing to change the mascot of his NFL team, the Washington Redskins. The Redskins, however, are far from being the only controversial mascot in sports history.  Here is a sampling of athletic teams from all areas of the sports world that were outside the norm.

    July 28, 2014 3 Photos

  • 'Rebel' mascot rising from the dead

    Students and alumni from a Richmond, Va.-area high school are seeking to revive the school's historic mascot, a Confederate soldier known as the "Rebel Man," spurring debate about the appropriateness of public school connections to the Civil War and its icons.

    July 28, 2014

AP Video
Texas Scientists Study Ebola Virus Smartphone Powered Paper Plane Debuts at Airshow Southern Accent Reduction Class Cancelled in TN Raw: Deadly Landslide Hits Indian Village Obama Chides House GOP for Pursuing Lawsuit New Bill Aims to Curb Sexual Assault on Campus Russia Counts Cost of New US, EU Sanctions 3Doodler Bring 3-D Printing to Your Hand Six PA Cops Indicted for Robbing Drug Dealers Britain Testing Driverless Cars on Roadways Raw: Thousands Flocking to German Crop Circle At Least 20 Chikungunya Cases in New Jersey Raw: Obama Eats Ribs in Kansas City In Virginia, the Rise of a New Space Coast Raw: Otters Enjoy Water Slides at Japan Zoo NCAA Settles Head-injury Suit, Will Change Rules Raw: Amphibious Landing Practice in Hawaii Raw: Weapons Fire Hits UN School in Gaza Raw: Rocket Launches Into Space With Cargo Ship Broken Water Main Floods UCLA
Stocks
Poll

Are you pleased that Oklahoma has repealed Common Core standards for public school students?

Yes
No
     View Results