Vivesto AB, an oncology-focused development company, has been confirmed as intended for a Limited Market by the European Medicines Agency for treating splenic hemangiosarcoma in dogs following splenectomy.
The Limited Market classification is equivalent to the US MUMS classification, which Vivesto received for Paccal Vet in 2023. It is intended for products that treat or prevent diseases affecting a small patient population. The benefits of this classification include potentially reduced data requirements and enhanced regulatory assistance. The authorization is valid for five years and renewable every five years afterward.
Vivesto's drug candidate, Paccal Vet, consists of paclitaxel formulated using the company's proprietary XR-17 technology, which has demonstrated good safety for treating various types of cancer in dogs. The absence of solvent cremophor, which dogs are susceptible to, may reduce the risk of serious side effects and casualties associated with treatment. Additionally, Paccal Vet does not require the addition of human albumin, which can cause hypersensitivity reactions and reduced treatment effectiveness in dogs.
“We are very happy to have gained the Limited Market classification, aiming to increase the availability of treatments for serious or life-threatening animal diseases and unmet veterinary medical needs. This brings Vivesto one step closer to our goal of bringing Paccal Vet to the market to help the 75,000 dogs diagnosed with hemangiosarcoma annually in Europe,” said Erik Kinnman, CEO of Vivesto.
Vivesto is a Swedish development company that offers new treatment options for hard-to-treat cancers with major medical needs and significant market potential. Their veterinary oncology program Paccal Vet is being evaluated in a pilot clinical trial in dogs with splenic hemangiosarcoma following splenectomy.
Comments