San Francisco, California – November 8, 2019 – OKAVA Pharmaceuticals, Inc., a clinical stage research and development company focused on diseases of aging in dogs and cats, today announced that the company was granted a Minor Use/Minor Species (MUMS) Drug Designation for OKV-1001 by the FDA. OKV-1001 is a modified release mycophenolate that is being developed for immune-mediated hemolytic anemia in dogs.

The Center for Veterinary Medicine (CVM), a division of U.S. Food and Drug Administration, Minor Use/Minor Species (MUMS) program was developed to support new animal drugs intended for uncommon or undertreated diseases such as IMHA.

“IMHA is a debilitating disease with no approved treatment options,” said Michael Klotsman, PhD, MBA, the chief executive officer of OKAVA. “IMHA has been ignored by far too long by the established animal health companies. Given the success of treating human IMHA patients with mycophenolate, we believe OKV-1001 has the potential to tackle this disease in dogs.”

The MUMS Drug Designation is modeled on the “Orphan Drug Act” for humans. It grants OKAVA seven years of exclusive market rights, which means that OKAVA will face no competition during that time period. The designation also makes OKV-1001 eligible for conditional approval. Accelerated conditional approval, once received, will allow OKAVA to market the drug and will then have up to five years to submit additional data for full approval.