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.
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