QBiotics receives first registration for tigilanol tiglate with European Medicines Agency approval of STELFONTA®
STELFONTA® (tigilanol tiglate) has been approved by the European Medicines Agency (EMA), making it the first pharmaceutical treatment available for all grades of canine non-metastatic mast cell tumours (MCT). The approval marks the first registration of QBiotics' lead compound tigilanol tiglate, which is also under review by the US Food and Drug Administration - Center for Veterinary Medicine (FDA-CVM) and the Australian Pesticides and Veterinary Medicines Authority (APVMA). The approval is supported by a full technical data package focused on safety and efficacy including a pivotal study in 123 canine patients where a single injection of STELFONTA® completely removed (Complete Response) 75% of treated MCT. QBiotics have partnered with Virbac, who will be launching STELFONTA® across key EU markets in the coming months.