Drug Development

J&J takes one of its top blockbuster prospects to the FDA, in search of a big approval

MorphoSys CSO Marlies Sproll

MorphoSys CSO Marlies Sproll

Hot on the heels of a new round of Phase III data showing that their IL-23 drug guselkumab handily beat out Humira in treating severe plaque psoriasis, J&J has submitted the drug for approval at the FDA.

That’s good news for MorphoSys, which out-licensed the drug to the pharma giant. The biotech now gains a new milestone from their deal on this drug, which analysts believe is a likely blockbuster-in-the-making with a multibillion-dollar peak sales estimate. Last year J&J listed this drug, which has distinguished itself from rivals tied to some severe side effects, as one of 10 potential blockbusters it had in late-stage testing.

“If the FDA grants approval, guselkumab could become the first marketed antibody based on MorphoSys’s proprietary antibody technology – with more than 100 other MorphoSys compounds currently in development,” noted MorphoSys CSO Marlies Sproll.

This fast-moving field has seen plenty of drama over the past year. At one point AstraZeneca and Amgen thought they were on track with brodalumab, then incidents of suicidal ideation drove Amgen out and persuaded AstraZeneca to sell rights to the drug to a troubled Valeant, which won a recent panel vote.

In the meantime, Eli Lilly made it onto the market with Taltz (ixekizumab) with Novartis out with the first new contender, Cosentyx. Merck is still in the clinic with MK-3222.

J&J believes it can top the field, and after a recent setback with sirukumab, they’ll likely push it hard once it hits the market.


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RAPS Regulatory Convergence 2017