IBJNews

Lilly diabetes drug wins backing from EU regulator

Back to TopCommentsE-mailPrintBookmark and Share

A European Medicines Agency panel recommended approving a diabetes drug from Boehringer Ingelheim GmbH and Eli Lilly and Co. that was rejected this month in the United States because of manufacturing deficiencies.

The medicine, Jardiance, should be approved as a treatment for type 2 diabetes, the agency’s Committee for Medicinal Products for Human Use said in a prepared statement Friday. The European Commission usually follows the panel’s advice.

Indianapolis-based Lilly is expected to garner $518 million in annual sales from Jardiance by 2019, according to the average of five analyst estimates compiled by Bloomberg.

The Food and Drug Administration said this month it wouldn’t approve the drug until Boehringer fixes the problems disclosed in May after a 2012 inspection of a plant in Ingelheim am Rhein, Germany, where the closely held company is based. The FDA completed its re-inspection of Boehringer’s plant March 7, the company said.

The treatment, also known as empagliflozin, is part of a class of medicines that includes Johnson & Johnson’s Invokana and AstraZeneca Plc’s Forxiga. The drugs help the body get rid of sugar through the kidneys. Type 2 diabetes, the most common kind, is often driven by obesity, as the body loses its ability to process sugar. The disease may be the seventh leading cause of death in the world by 2030, according to the World Health Organization.

 

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. The $104K to CRC would go toward debts service on $486M of existing debt they already have from other things outside this project. Keystone buys the bonds for 3.8M from CRC, and CRC in turn pays for the parking and site work, and some time later CRC buys them back (with interest) from the projected annual property tax revenue from the entire TIF district (est. $415K / yr. from just this property, plus more from all the other property in the TIF district), which in theory would be about a 10-year term, give-or-take. CRC is basically betting on the future, that property values will increase, driving up the tax revenue to the limit of the annual increase cap on commercial property (I think that's 3%). It should be noted that Keystone can't print money (unlike the Federal Treasury) so commercial property tax can only come from consumers, in this case the apartment renters and consumers of the goods and services offered by the ground floor retailers, and employees in the form of lower non-mandatory compensation items, such as bonuses, benefits, 401K match, etc.

  2. $3B would hurt Lilly's bottom line if there were no insurance or Indemnity Agreement, but there is no way that large an award will be upheld on appeal. What's surprising is that the trial judge refused to reduce it. She must have thought there was evidence of a flagrant, unconscionable coverup and wanted to send a message.

  3. As a self-employed individual, I always saw outrageous price increases every year in a health insurance plan with preexisting condition costs -- something most employed groups never had to worry about. With spouse, I saw ALL Indiana "free market answer" plans' premiums raise 25%-45% each year.

  4. It's not who you chose to build it's how they build it. Architects and engineers decide how and what to use to build. builders just do the work. Architects & engineers still think the tarp over the escalators out at airport will hold for third time when it snows, ice storms.

  5. http://www.abcactionnews.com/news/duke-energy-customers-angry-about-money-for-nothing

ADVERTISEMENT