The negative controversy of the JAK inhibitor continues, and its Opzelura is still a great success after the launch

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When Opzelura (ruxolitinib, a topical cream), the sister drug of Incyte's JAK inhibitor Jakafi (ruxolitinib, an oral tablet), enters the atopic dermatitis market with an unexpected FDA safety warning, industry watchers worry that doctors will refuse to prescribe the drug.
ointment
.

Incyte Chief Executive Herve Hoppenot said Tuesday that the launch of Opzelura has been "extremely successful" so far, with the topical cream reaching nearly 19,000 patients in the fourth quarter after its official launch in mid-October, with 500 sales.
million dollars
.

RBC Capital Markets analyst Brian Abrahams said in a note Tuesday that while the $5 million in sales fell short of the $7 million Wall Street had expected, patient benefit figures suggest Opzelura could hit $148 million in total sales in 2022 USD, well above the current Wall Street consensus forecast of $73 million
.

In September 2021, the FDA approved Opzelura cream, a topical JAK inhibitor, for short-term and non-sustaining chronic treatment of mild to moderate non-immunocompromised patients receiving topical prescription therapy that is not adequately controlled or when these therapies are not advisable Atopic dermatitis (AD) in adolescent (age ≥12 years) and adult patients
.

Incyte has ambitious plans for Opzelura: Herve Hoppenot predicts the drug could be worth $1.
5 billion in the U.
S.
atopic dermatitis market alone, despite a label on the drug about serious infections, deaths, cancer, heart-related Category-wide boxed warnings for events and blood clots affecting multiple JAK inhibitors
.

In Brian Abrahams' view, patient uptake is more important than sales figures during a drug's initial launch
.

Citing IQVIA data, Barry Flannelly said Opzelura had captured 10 percent of the new-brand post-steroid market in the months it was on the market, getting closer to the 13 percent held by Pfizer's rival Eucrisa Cream, which It has been on the market for 5 years
.

Feedback from physicians also indicated an increased willingness to use Opzelura
.

In terms of reimbursement, Incyte has signed base discount agreements with 2 of the three major commercial pharmacy benefit managers (PBMs), covering 55% of patients managed by the 2 systems, Barry Flannelly said
.

Opzelura's initial sales appeared to be weak, in part due to a high gross-to-net discount, including a huge impact from the company's patient support program
.

As for Pfizer's rival Eucrisa, the drug's launch was stumbled by deep discounts and unfavorable prescription coverage
.
Considering the huge atopic dermatitis market, Eucrisa was once seen as an asset with peak sales of more than $2 billion
.
But Eucrisa has disappeared from Pfizer's quarterly report as sales have become paltry
.

Meanwhile, with the launch of the atopic dermatitis indication, Incyte may receive regulatory approval from the FDA to expand Opzelura to vitiligo by April 18 this year
.
Incyte has also launched another Phase 3 clinical trial of Opzelura for the treatment of moderate to severe chronic hand eczema, which is estimated to affect 4% of the U.
S.
population
.
The study is expected to complete enrollment this year, with data expected in 2023, Incyte Chief Medical Officer Steven Stein told investors on a call
.

Encouraged by the initial strong launch, Incyte now expects Opzelura and its dermatology portfolio, which includes the JAK1 inhibitor INCB54707, to be a significant revenue driver going forward
.
In the fourth quarter of 2021, Incyte's total revenue was $813 million, up 20% year-over-year, mainly due to higher sales at Jakafi
.

Reference article: Incyte's eczema cream Opzelura off to 'very successful' launch despite FDA warning: CEO | FiercePharma