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Medivir AB. (8/16/17). "Press Release: FDA Accepts Medivir´s IND Application for MIV-711, Enabling Clinical Development in the US". Stockholm.

Region Region United States (USA)
Organisations Organisation Medivir AB (Nasdaq Stockholm: MVIR)
  Today Medivir (Group)
  Group Medivir (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product MIV-711 (Medivir)
  Product 2 clinical research
Person Person Holmgren, Åsa (Medivir 201708 EVP Strategic Regulatory Affairs and Market Access)
     


Medivir AB (Nasdaq Stockholm: MVIR) announces today that the Investigational New Drug (IND) application for MIV-711 has been accepted and the IND is now open with the FDA (U.S. Food and Drug Administration).

“We are very pleased to have received FDA acceptance for our IND. This is a regulatory milestone for MIV-711 and enables clinical development of MIV-711 in the US, in addition to the already completed and ongoing studies in Europe” says Åsa Holmgren, Medivir´s EVP Strategic Regulatory Affairs and Market Access.


About MIV-711

MIV-711 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.


For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile +46 (0)725-480 580


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.

   
Record changed: 2017-08-24

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