Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company´s product candidate MIV-711, for the treatment of osteoarthritis (OA).
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 (IND) 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 (DMOAD). There are currently no disease-modifying therapies approved for the treatment of OA and all approved treatments affect only day to day symptoms and have no effect on the degenerative changes in the diseased joint¹.
“We are very pleased that the FDA decided to grant a Fast Track designation to MIV-711. This is expected to accelerate the development and review of MIV-711, and underscores the high unmet medical need for a product that may address the disease progression in OA” said Åsa Holmgren, Medivir´s EVP Strategic Regulatory Affairs and Market Access.
For further information, please contact:
Christine Lind, CEO Medivir AB, phone +46 (0)8 5468 3100
Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 22.30 CET on 24 October 2017.
About MIV-711
MIV-711 is a potent and selective inhibitor of cathepsin K, the principal protease involved in breaking down collagen in bone and cartilage. It is being developed to slow or reverse the progressive degeneration of joints affected by osteoarthritis, and is therefore referred to as a Disease Modifying Osteoarthritis Drug (DMOAD). Since there are no DMOADs approved for use currently, the standard of care for osteoarthritis patients is based on changes in life style and the use of analgesics. The long-term use of analgesics by osteoarthritis patients is associated with an increased risk of side effects such as gastrointestinal bleeding and opioid dependency. DMOADs therefore represent a very large and attractive market opportunity. Medivir estimates that the US market alone is greater than USD 6 billion annually for a drug that impacts disease progression, even if its use was restricted just to patient populations with moderate osteoarthritis in weight-bearing joints.
About Medivir
Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List.
¹ https://www.oarsi.org/sites/default/files/docs/2016/oarsi_white_paper_oa_serious_disease_121416_1.pdf