CarriageTowneNews.com, Kingston, NH

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
Community News Network

New England News
Obituaries
  • Alan J. Walker, 68

    Kingston, N.H. — Mr. Alan James Walker, 68, passed away peacefully at his home on July 8, 2014, after a long, brave battle with cancer.

    Continued ...
    16 hours
  • James Reese

    Raymond, NH — James Edwin Reese, 74, passed away on Wednesday, July 16, 2014, surrounded by his family and friends at his home in Raymond, N.H. He was the son of John and Ruth Reese, born on Oct. 29, 1939 in Edensburg, Pa. James graduated from Central Cambria High School in Pennsylvania before proudly serving in the U.S. Army as a food inspector. His military service was followed by 31 years with the U.S. Department of Agriculture as a meat inspector. Mr. Reese was an avid outdoorsman and spent much of his time fishing, camping and hiking in the White Mountains. He became involved in the Boy Scouts and enjoyed passing on his vast knowledge of the wilderness to others. Throughout his retirement years he enjoyed woodworking, raising rabbits and working in his garden.

    Continued ...
    16 hours 1 Photo
  • Velma J. Reid

    South Hampton, NH — Velma J. Reid, 80, died peacefully on July 17, 2014 at Exeter Hospital, surrounded by family. She was born in Haverhill, Mass. on June 8, 1934, the daughter of the late George C.W. and Alta I. (Kimball) Haynes. A graduate of Haverhill High School, Velma worked at Western Electric until she had children. For years, she was a devoted “stay-at-home” mom who raised her three children in a loving, nurturing environment. She later worked various manufacturing jobs until her retirement. After retiring, she volunteered her time at various organizations and was very involved at the East Kingston Community United Methodist Church as a member of the women’s guild, assisting with the holiday fair, and helping out wherever she could. She had a passion for animals, and would donate money, food, and blankets to the NH SPCA. She loved to sew and made a personalized quilt for every member of her family. She was also a member of the “Ugly Quilts” group, which made blankets and sleeping bags for the homeless using recycled fabric. She is survived by her husband, Clyde Reid of South Hampton, N.H.; daughter, Pam Eaton of Danville, N.H.; son and daughter-in-law, Douglas and Kim Reid of Raymond, N.H.; daughter, Shirley Reid of South Hampton, N.H.; two sisters, Gwen Stuart of Haverhill, and Norma Taplin of Dracut; four grandchildren, Cheryl and Marc Welch, and Kristen and Joshua Reid, and several nieces and nephews.

    Continued ...
    16 hours 1 Photo
  • Carleen A. Knowlton, 80

    Danville, NH — Carleen A. (Rhoadhouse) Knowlton, 80, of Danville and formerly of Hampstead, died on July 7, 2014, at her home.

    Continued ...
    7 days 1 Photo
  • Miriam O. (Graham) Graham, 84

    Kingston, NH — Miriam O. (Graham) Graham, 84, a resident of Kingston since 2001, and former longtime resident of Grafton, Mass., died peacefully, surrounded by her family, on July 11, 2014, following a long illness.

    Continued ...
    7 days 1 Photo

Stocks