Sun Pharma gets US FDA approval for plaque psoriasis drug ILUMYA
Sun Pharmaceuticals' ILUMYA is administered at a dose of 100mg by subcutaneous injection for the treatment of moderate-to-severe plaque psoriasis
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Business News/ Industry / Manufacturing/ Sun Pharma gets US FDA approval for plaque psoriasis drug ILUMYA
Mumbai: India’s largest drug marker, Sun Pharmaceuticals Ltd Wednesday said the US Food and Drug Administration (FDA) has approved its drug ILUMYA (tildrakizumab) for the treatment of moderate-to-severe plaque psoriasis.
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ILUMYA is administered at a dose of 100mg by subcutaneous injection. “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," Abhay Gandhi, president and chief executive officer, North America, Sun Pharma said in a statement.
With this, Sun Pharmaceuticals is poised to become one of the handful of companies in India to launch a novel biological entity in the US market. While the price and date of launch is yet to be decided by the company, the company is evaluating European market for the next launch.
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Sun Pharmaceuticals acquired worldwide rights to tildrakizumab from Merck for $80 million in 2014, taking the responsibility for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.
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