Mastitis preventive gets joint Canada/U.S. approval

A new drug to help limit mastitis in dairy cows — and keep a lid on the use of antimicrobials to treat it — has picked up joint approval from Health Canada and the U.S. Food and Drug Administration.

The two agencies on Thursday announced “simultaneous” approvals for Elanco Animal Health’s injectable drug pegbovigrastim, to be sold under the brand name Imrestor.

The drug is approved for reducing incidence of clinical mastitis in the first 30 days of lactation in dairy cows and replacement dairy heifers at the periparturient stage — that is, the time frame just before, during and just after calving.

Elanco, in a separate release last week, billed Imrestor as 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.”

Around calving, the company said, dairy cows show suppressed levels of neutrophils, the white blood cells that recognize and destroy harmful bacteria. Imrestor, Elanco said, “helps restore the function and increase the number of neutrophils at calving.”

Given that mastitis is the most common illness treated with antimicrobials in dairy cows, the company said, the new drug lines up well with the company’s antibiotic stewardship plan, which is meant to promote responsible use of antibiotics, reduce shared-class antibiotic use and replace antibiotics with alternatives.

Clinical mastitis — which Elanco said is known to affect up to one in four cows — is an inflammation in a cow’s mammary gland and udder tissue, caused by staph, strep and E. coli bacteria, among others.

The infection can reduce milk yield, damage udder tissues and reduce calf conception rates, create severe pain for the infected animal and leave it open to increased risk for future mastitis infections.

Elanco said last week its efficacy studies for regulatory approval showed a 28 per cent reduction in clinical mastitis incidence among cows and heifers that received Imrestor, compared with animals in its control groups.

“This drug’s approval will provide Canadian dairy farmers with access to an innovative product to treat a common but serious condition, and likely lead to fewer animals needing treatment from antimicrobial drugs,” Canada’s Health Minister Jane Philpott said in an agency release Thursday.

“Thanks to our government’s collaboration with our American counterparts, the approval was able to be expedited and will help to improve the health and well-being of Canadian cattle.”

Imrestor’s approval is the first for a use in food-producing animals under the Canadian/U.S. Regulatory Co-operation Council (RCC), and the fourth drug overall to get approval through the RCC process, Health Canada said.

The RCC is a Canada/U.S. pact to improve “regulatory transparency and co-ordination” between the two countries. — AGCanada.com Network

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