Vivesto AB, a Swedish oncology-focused development company, announced that its drug candidate Paccal Vet has received Limited Market classification from the European Medicines Agency (EMA) for the treatment of splenic hemangiosarcoma (HSA) in dogs following splenectomy. This designation may pave the way for a faster regulatory approval process in the EU.
Regulatory Pathway and Market Exclusivity
The Limited Market classification is the EU's equivalent to the US Minor Use and Minor Species (MUMS) classification, which Paccal Vet received in 2023. It is reserved for products targeting diseases that occur infrequently in the EU. Benefits include potentially reduced data requirements and enhanced regulatory support. This classification allows for authorization with a reduced clinical data package, similar to the US conditional approval based on safety data and a reasonable expectation of efficacy, potentially waiving the requirement for a pivotal study. The authorization is valid for five years and is renewable thereafter.
Clinical Significance and Unmet Need
According to Vivesto CEO Erik Kinnman, this classification aims 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," Kinnman stated.
About Paccal Vet
Paccal Vet consists of paclitaxel formulated with Vivesto's proprietary XR-17 technology. Previous studies have demonstrated the safety of Paccal Vet in treating various types of cancer in dogs. The formulation avoids the use of cremophor, a solvent to which dogs are particularly sensitive, potentially reducing the risk of severe side effects. Additionally, Paccal Vet does not require the addition of human albumin, which can cause hypersensitivity reactions and reduce treatment effectiveness in dogs.
Clinical studies have shown safety in over 300 dogs, with anti-tumor activity observed in squamous cell carcinoma and non-resectable mammary carcinoma of stage III-V.
