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Minor Use designation applies for drugs treating animal diseases that occur infrequently or in a small number of animals annually in the US. Designated new animal drugs that first receive FDA approval in a specific indication are granted seven years of marketing exclusivity, which means that Paccal Vet would be protected from generic competition for the approved use during that time. Further incentives such as regulatory support and fee reductions are provided.
The development program for Paccal Vet was discussed with the FDA earlier this year. No further FDA approval will be necessary prior to the start of the planned clinical pilot study in dogs with splenic hemangiosarcoma following splenectomy, and the first patient in the study is expected to be treated early 2024.
“It is very encouraging to get the MUMS designation for our oncology veterinary product Paccal Vet. Not only will the designation provide several advantages and potentially reduce the cost and time to market authorization and launch, it is also a positive signal from the FDA that Paccal Vet potentially has an important role to play in the treatment of this severe cancer type,” said
The MUMS Act was modeled on the Orphan Drug Act for humans, which encourages pharmaceutical sponsors to develop drugs for rare diseases in people, by providing incentives for approval. Incentives include market exclusivity for the specific intended use. Moreover, a sponsor of a designated new animal drug is also eligible to apply for grants to cover the cost of related clinical studies.
About splenic hemangiosarcoma in dogs
Hemangiosarcoma is one of the most common malignant cancers in dogs and is associated with a poor prognosis, with less than 10 percent of dogs surviving 12 months. The number of dogs diagnosed with hemangiosarcoma annually in the US and
Treatment options for hemangiosarcoma include surgery and, for some of the dogs, an unapproved adjuvant chemotherapy. The median survival time for dogs with hemangiosarcoma of the spleen undergoing surgery alone is approximately 1-3 months, depending on the stage/seriousness of the disease. Chemotherapeutic agents are used to manage residual metastatic disease after surgery. The most common chemotherapy program in use today can extend survival with hemangiosarcoma of the spleen by 2-4 months.
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