Sun Pharma Says FDA Accepts Supplemental Application for ILUMYA

US Food and Drug Administration has accepted for review Sun Pharmaceutical Industries’ supplemental Biologics License Application for ILUMYA, the drugmaker said in a statement to exchanges.

• Co.’s sBLA is for using the drug for treatment of adults with active psoriatic arthritis
  • The FDA regulatory action date for this application is expected by Oct. 29
• If approved, this would allow use of ILUMYA for a new indication
  • In 2018, US FDA approved the drug for the treatment of adults with moderate-to-severe plaque psoriasis
  • Applications for Scalp and nail plaque psoriasis were also approved later
• ILUMYA has received marketing authorization ...