Active Biotech wins FDA’s Orphan Drug Designation for its multiple myeloma drug

U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Active Biotech for its investigational novel agent tasquinimod, for the treatment of multiple myeloma.

This designation provides for a seven year marketing exclusivity period against competition, as well as certain incentives. Also, tasquinimod has patent protection in multiple myeloma until 2035, Active Biotech said in its press release on Wednesday.

The development of tasquinimod has previously been focused on the treatment of prostate cancer with clinical proof of concept and a good safety profile shown in Phase 2 and 3 studies. Active Biotech said that it is seeking a partner for the continued development of tasquinimod in multiple myeloma.

The company explained that tasquinimod is an immunomodulatory, anti-metastatic and anti-angiogenic compound that affects the tumor’s ability to grow and spread. Tasquinimod acts on immunosuppressive cells that play a key role in tumor progression in multiple myeloma due to their capability to promote immune-escape, angiogenesis, and metastasis.