MUMBAI: Sun Pharmaannounced that US Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn) for the treatment of moderate-to-severe plaque psoriasis of adults, who are candidates for systemic therapy or phototherapy.
“With the approval of Ilumya and our long-standing commitment in dermatology, we are focused on making a difference for people living with moderate-to-severe plaque psoriasis,” said Abhay Gandhi, president and CEO North America, Sun Pharma.
The FDA approval of Ilumya for the treatment of adults with moderate-to-severe plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development programme, says a release.
Sun Pharmaceutical wholly-owned subsidiary licensed worldwide rights to Ilumya from a subsidiary of Merck & Co in 2014. Funded by a Sun Pharma subsidiary, US-based Merck & Co was responsible for the completion of Phase-3 trials and submission of a biologics license application to USFDA, as well as manufacturing finished goods to support Sun Pharma’s initial product launch.
Sun Pharma will be responsible for all post-approval regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.