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Elanco gets FDA approval of new mastitis drug

By Staff | Apr 7, 2016

GREENFIELD Ind. (Elanco) Elanco Animal Health, a division of Eli Lilly and Co., announced March 17 the approval of Imrestor, the first product of its kind for the dairy industry.

Available only by veterinary prescription, Imrestor is now FDA approved for the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows and periparturient replacement dairy heifers.

Imrestor is a protein that helps support the natural function of a dairy cow’s immune system during the critical time around calving, when she is most vulnerable to mastitis.

“Imrestor is an innovative new approach for reducing clinical mastitis by proactively helping to restore the function of a cow’s immune system,” said Paul Rapnicki, associate technical advisor, Elanco Animal Health.

Pivotal efficacy studies conducted for FDA approval showed a 28 percent reduction in clinical mastitis incidence among cows and heifers that received Imrestor compared with control animals.

These include:

  • Immune suppression at calving can leave cows vulnerable to infection and an increased risk of mastitis.
  • Dairy cows and heifers are in need of protection particularly at calving due to a decline in neutrophils, the primary type of white blood cell that recognizes and destroys harmful bacteria. Imrestor helps restore the function and increase the number of neutrophils at calving which helps the cow to fight invading bacteria that cause mastitis.

The launch of Imrestor is aligned with Elanco’s eight-point antibiotic stewardship plan that ensures the responsible use of antibiotics, reduces shared-class antibiotic use and replaces antibiotics with alternatives.

The plan was outlined by Elanco President Jeff Simmons at a White House antibiotic stewardship forum last year.

Available in pre-filled, single-dose syringes, Imrestor is administered with two injections – one seven days prior to the anticipated date of calving, and the other within 24 hours after calving, helping to protect the cow against mastitis when she needs it most.

Imrestor does not require a meat or milk withdrawal period. Imrestor will be available for purchase.

A product availability date will be announced at a later time.

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