The European Medicines Agency (EMA) has designated Vivesto AB's drug candidate, Paccal Vet, for Limited Market, a decision that could accelerate its path to regulatory approval within the European Union. This classification is reserved for treatments addressing serious or life-threatening animal diseases with unmet veterinary needs.
According to Vivesto, the Limited Market designation may lead to a faster regulatory review process. If Paccal Vet gains approval, it will be granted 10 years of protection from generic competition within the EU market.
"We are very pleased to have received the Limited Market classification, which aims to increase the availability of treatments for serious or life-threatening animal diseases and unmet veterinary needs. The classification brings Vivesto one step closer to our goal of bringing Paccal Vet to the market to help the 75,000 dogs diagnosed with hemangiosarcoma in Europe each year," stated Erik Kinnman, CEO of Vivesto.
Paccal Vet is specifically designed for the treatment of hemangiosarcoma of the spleen in canines following splenectomy. Hemangiosarcoma is an aggressive cancer that affects approximately 75,000 dogs in Europe annually, representing a significant veterinary challenge. The current standard of care often involves surgery followed by chemotherapy, but the prognosis remains poor, highlighting the need for innovative therapeutic options like Paccal Vet.
