First monoclonal antibody in veterinary medicine suggested for a marketing authorization

By 27th February 2017 Other No Comments

At its February meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) suggested the permitting of a marketing authorization in the European Union (EU) for Cytopoint. This is a solution for injection containing the new active substance lokivetmab, the first monoclonal antibody in a veterinary medicine in the EU. It is proposed for the treatment of dogs with atopic dermatitis, a common allergic skin disease.

A monoclonal antibody (mAb) is an immune protein that identifies and impasses to a definite target protein. Lokivetmab is a caninised mAb developed by biotechnology that specifically targets and constrains canine interleukin-31 (IL-31), an immune protein that plays an important role in atopic dermatitis.

In dogs with this disease, the immune system reacts improperly when the animal comes in contact with allergens found in the environment causing itchy skin. Once the dog’s skin gets damaged by scratching and rubbing, secondary bacterial and yeast infections may develop as well.

The effectiveness of this medicine was assessed in a number of controlled laboratory and clinical studies. The data showed that treatment with Cytopoint reduced itching and the severity of skin disease in dogs receiving the medicine at the proposed dose of 1 mg/kg.

Cytopoint starts working within eight hours after administration and the effect lasts for up to 28 days. It comes in four different dosage forms (10, 20, 30 and 40 mg/ml) for administration to dogs of varying bodyweight.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/02/news_detail_002696.jsp&mid=WC0b01ac058004d5c1

Dated: 17th Feb 2017