Incyte changes manufacturing process and adds second site to fix Opzelura texture issue – Endpoints News

Barry Flannel

From the start of Incyte’s first quarter earnings call, the manufacturing issues surrounding Opzelura were addressed by Hervé Hoppenot, the company’s CEO. And although problems have slowed processing, the drug company said it added a second manufacturing site to produce the atopic dermatitis drug and implemented a new process after winning FDA approval.

“In accordance with best practices, we have received FDA approval for a second manufacturer of Opzelura to support our successful launch,” he said, before handing over to US Chief Executive Barry Flannelly. “We are also preparing to reintroduce samples to the United States.”

Units at the second site are being integrated right now, according to CMO Steven Stein, and will be in the field and with patients in the “coming weeks.”

Steven Stein

The issues stem from problems with the texture of the processing. A patient found strands of clear crystals, and Incyte says this is the result of an active pharmaceutical ingredient that came out of solution. Incyte has implemented a process change called CBE-30 that claims to improve solubility, and this change has already received the green light from the FDA.

So far, 68,000 prescriptions for Opzelura have been made, and Stein said the number of complaints is down. The change in the manufacturing process did not fundamentally change anything. Incyte launched a marketing campaign for Opzeulura at the Oscars in late March.

And the market reacted. The drug achieved sales of $90 million in the first quarter and gained 38,000 new patients during the same period. Patients are requesting refills, accounting for 23% of prescriptions in the last week of the first trimester, which Flannelly says is a good indicator of the drug’s longevity. More than 7,500 doctors have prescribed the drug and the team expects the number of prescriptions to double in the coming months.

“The launch of Opzelura continued to be very successful with strong adoption by dermatologists, high satisfaction reported by both patients and physicians, and significant progress with payers,” Hoppenot said.

Patients switch from steroids to Opzeulra. Flannelly and Hoppenot both insist that the number of prescription refills is a good indicator of patient satisfaction with treatment.

In 2021, consecutive three-month delays prevented Opzelura from being approved, as safety alerts were sent with the labels. Last March, it received a similar delay in its PDUFA deadline for the fate of its ruxolitinib cream on the market for the treatment of vitiligo. Opzelura was the first topical JAK inhibitor approved in the United States and is indicated for AD patients ages 12 and older who struggle to control their disease with other prescription creams.

Hoppenot previously put a sales estimate of $1.5 billion in the United States, though analysts have been skeptical of the figure. The number was called unachievable, largely due to patient cost barriers and the high gross-to-net ratio.


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