24 October 2017 - Medivir today announced that the U.S. FDA has granted fast track designation for the company´s product candidate MIV-711, for the treatment of osteoarthritis.

The FDA´s fast track program is designed to facilitate the development and expedite the review of drugs that are intended to treat serious conditions. In order to receive fast track designation, a product must also demonstrate the potential to fill an unmet medical need. The purpose is to get important new drugs to patients earlier. The FDA has previously cleared an investigational new drug application for MIV-711.

Previously announced results from a phase IIa study showed that MIV-711 demonstrated benefit on joint structure and thereby has the potential to act as a disease-modifying osteoarthritis drug. There are currently no disease-modifying therapies approved for the treatment of osteoarthritis and all approved treatments affect only day to day symptoms and have no effect on the degenerative changes in the diseased joint.

Read Medivir press release