Solensia

The medicine can only be obtained with a prescription.

Solensia is a solution for injection for cats. It is to be given subcutaneously (under the skin); the recommended dose is 1 to 2.8 mg/kg bodyweight, once a month.

For more information about using Solensia, see the package leaflet or contact your veterinarian or pharmacist.

The active substance in Solensia is frunevetmab, a felinised monoclonal antibody (a type of cat-specific protein) designed to recognise and attach to a protein called nerve growth factor (NGF), which is involved in the regulation of pain. When frunevetmab binds to NGF, it prevents the bound NGF from attaching to its receptors on nerve cells where it regulates pain signalling. This way, it helps relieve pain associated with osteoarthritis.

Solensia was investigated in three field studies, a main one and two exploratory studies. All the studies were conducted in veterinary practices in the USA.

The pivotal field trial included 275 otherwise healthy cats with clinical signs of osteoarthritis in at least two joints or spinal segments, which showed pain. The cats received either the recommended dose (1 to 2.8 mg/kg bodyweight) of Solensia or a placebo (dummy treatment) once a month for three months.

The main measure of treatment success was a pain score (on a scale of 3 to 15) assessed by owners, using a standard rating scale known as Client-Specific Outcome Measures (CSOM). CSOM rates a cat’s response to pain treatment by looking at the cat’s physical activity, sociability and quality of life.

Around 76% of cats who received frunevetmab had a successful treatment (defined as a reduction of at least 2 points in the total CSOM score and no increase in any individual score). This compares with 65% of cats who received placebo.

The most common side effects with Solensia (which may affect up to 1 in 10 animals) are skin reactions (itching, skin inflammation and hair loss).

Solensia should not be used in cats under 1 year of age or weighing less than 2.5 kg. It is also not for cats intended for breeding or cats that are pregnant or nursing kittens. For the full list of restrictions, see the package leaflet.

Safety information has been included in the summary of product characteristics and the package leaflet for Solensia, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection. Repeated accidental self-administration may increase the risk of hypersensitivity reactions. Pregnant women, women trying to conceive, and breastfeeding women should take extreme care to avoid accidental self-injection. In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

The main study showed that Solensia was effective at reducing pain in cats with osteoarthritis, and the side effects are manageable. The European Medicines Agency therefore decided that Solensia’s benefits are greater than its risks and it can be authorised for use in the EU.

Solensia received a marketing authorisation valid throughout the EU on 17 February 2021.