Sweden’s research-oriented pharmaceutical firm Medivir AB's Investigational New Drug (IND) application for an osteoarthritis treatment has been accepted by, and is currently open with, the U.S. Food and Drug Administration.
"We are very pleased to have received FDA acceptance for our IND," Åsa Holmgren, Medivir´s executive vice president for strategic regulatory affairs and market access, said. “This is a regulatory milestone for MIV-711 and enables clinical development of MIV-711 in the U.S., in addition to the already completed and ongoing studies in Europe.”
Medivir’s MIV-711 product — under development to potentially decelerate or reverse progressive joint degeneration caused by osteoarthritis — is classified as a Disease Modifying Osteoarthritis Drug (DMOAD). Since no DMOADs are yet approved, practitioners have approached the disease largely by prescribing analgesics and recommending lifestyle adjustments.
Because long-term analgesic use is not without risks — such as gastrointestinal bleeding and dependency issues — Medivir officials indicated that DMOADS present a significant possibility for widespread treatment.
“[The] U.S. market alone is greater than $6 billion annually for a drug that impacts disease progression, even if its use was restricted … to patient populations with moderate osteoarthritis in weight-bearing joints,” the company said in a press release.
Medivir specializes in oncology. With headquarters in Stockholm, the company works with protease inhibitor design and nucleic acid-based science.