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For Incyte’s eczema cream Opzelura, consumer complaint reveals ongoing quality woes, replacement backlog

When Gale Wild-Ebers, 62, ordered a second tube of Incyte’s topical eczema drug Opzelura in March, something appeared wrong with the product she received. Instead of the medicine having a consistent texture of cream, she found “small, clear, elongated crystals.”

Upon the discovery, Wild-Ebers contacted her pharmacy and was referred to Incyte’s patient support phone line, where she filed a complaint and was told that someone would be in contact about a replacement.

“They did say it was safe, but I was not comfortable using it as there could be additional issues with it that I was not made aware of,” Wild-Ebers said in an email to Fierce Pharma. She suspended use of the tube, and her doctor prescribed another topical drug as a fill-in as she awaited the replacement.

After more than a week without receiving a follow-up, Wild-Ebers called Incyte once again. At that time, an Incyte representative told her the company was dealing with a backlog and promised a reply within a few more days.

Monday, Wild-Ebers told Fierce Pharma that Incyte had finally confirmed a replacement and asked for the problematic tube back. That was 18 days after Wild-Ebers’ initial call.

The quality problem Wild-Ebers experienced seems to have lingered for at least several months. During a conference call in November about Incyte’s third-quarter earnings, Barry Flannelly, Incyte’s general manager of North America, revealed that the company had received three separate complaints of a texture problem with Opzelura’s sample and commercial products.

At that time, the company said the issue was caused by “a very small quantity of active product ingredient (API) not being completely dissolved, which has, on occasion, produced a slightly gritty texture.” The company promised a root cause analysis to ensure “continued product quality and supply.”

Incyte didn’t respond to several requests for comment in the past few days.

The company launched Opzelura as a new atopic dermatitis treatment option back in September. Based on a large patient population of 5.5 million people and average annual use of three to four tubes per patient, Incyte has projected $1.5 billion in peak U.S. sales for Opzelura in eczema alone.

But despite a classwide safety warning and an ominous example of a similar launch that failed in Pfizer’s Eucrisa, Opzelura has delivered a strong start. In January, nearly 11,000 tubes of Opzelura were shipped from wholesalers to pharmacies, Flannelly said during a conference call in February. The number closely reflects prescriptions given retailers typically hold a low level of inventories for specialty dermatology therapies, he said.

Based on Opzelura’s early uptake trajectory, RBC Capital Markets analyst Brian Abrahams wrote to clients Sunday that Opzelura could ultimately reach 75,000 patients this year. He thinks the drug could generate $153 million in 2022 sales, handily beating Wall Street’s expectations.

Physician feedback also appears to favor Opzelura. A dermatologist expert who practices at “a major northeastern medical center” cited “excellent” experiences with Opzelura with clear efficacy and good tolerability, RBC said in a note last week. The doctor sees a place for Opzelura after generic topical drugs or in combination with systemic biologics such as Sanofi and Regeneron’s Dupixent.

Wild-Ebers was using Opzelura off-label for a skin condition called macular amyloidosis, which causes itching and dark brown skin patches. She had previously tried several generic topical drugs and over-the-counter products. Her doctor figured Opzelura was worth a try after the other meds didn’t work so well.

She received her first Opzelura tube in December and experienced no side effects nor any product quality issues. She ordered the second tube because it would take months for any relief in symptoms to show up, she said.

“I would have continued it if the company had sent a new tube without the crystals,” she said. “I may revisit the Opzelura in the future, but at this point I need to give the new medication a try for a while.”