Incyte’s Opzelura is off to a promising launch, as indicated by a variety of metrics the company highlighted on Tuesday, but manufacturing troubles have threatened to hold the atopic dermatitis treatment back.
Incyte has taken steps to solve those issues, and those tweaks have passed muster with regulators, the company said during its first-quarter conference call.
“We have recently received FDA approval and have implemented a new manufacturing process to improve the production of (active product ingredient) for the launch,” Incyte CEO Hervé Hoppenot said.
Incyte also has added a second manufacturing site to produce Opzelura which is “coming onboard as we speak,” Incyte’s chief medical officer, Steven Stein, M.D., said.
“Those units from that second site will—over the next couple of weeks—be out in the field and with patients,” Stein added. “We absolutely expect within the next week or so to begin the sampling program as well, given that now we have a batch made for that.”