Plaque psoriasis drug Ilumya approved by FDA

The US Food and Drug Administration has approved Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The New Drug Application was submitted by India drug major Sun Pharmaceuticals (BSE: 524715), which acquired rights to tildrakizumab from Merck & Co (NYSE: MRK) in September 2014 in exchange for an upfront payment of $80 million. In Europe, Spain’s Almirall (ALM: MC) has been granted development and commercialization rights to the drug by Sun Pharma, which received an initial upfront of $50 million as part of the deal.

Ilumya, which is Sun Pharma’s first biological drug, selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro-inflammatory cytokines and chemokines. The drug will be manufactured by South Korea’s Samsung BioLogics, under a $55.5 million contract.