Oasmia gets a confirmation
FDA has granted Oasmia an expedited review status for Paclical Vet.
The US Food and Drug Administration Center for Veterinary Medicine grants ERSs to certain products classified as important advances in animal health receive priority review beginning at the Investigational New Animal Drug, INAD, stage, but with no diminished standards for data quality or evaluation.ERS is reserved only for products that FDA believes represent an important therapeutic gain. In most cases this is restricted to drugs that are indicated for a life-threatening or severely debilitating disease for which there is no other approved treatment available.
Because of the importance of these products to animal health, the FDA review time is half as long as those assigned to products without ERS. Normally, the review time assigned to a submission is 180 days. Products under ERS will have a review clock of 90 days. In theory, this should significantly shorten the time to approval.
Oasmia also presents solid scientific evidence for Paccal Vet. Two clinical studies was recently completed in client owned dogs with Paccal Vet. The first was a phase I/II study on different types of cancers and showed an overall reponse rate of 74 per cent. The other was a phase III study on mastocytoma grade II and III and showed a response rate of 70 per cent. No unexpected severe side-effects were observed. The phase I/II study of Paccal Vet in tumors in dogs refractory to standard treatment Paclitaxel requires extensive premedication and slow infusion due to side effects caused by the solvent Cremophor EL.
The study was performed at eight sites, six in Sweden and one in Austria, and Germanyrespectively and was approved by the Regulatory Agencies and Ethics Committees concerned.