Leo Pharma prepares to come for the topical JAK market as Incyte's Opzelura cream launch cools off

2024-05-03
临床3期上市批准临床结果
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Watch out, Incyte. Leo Pharma and its JAK inhibitor cream delgocitinib are coming to disrupt the topical atopic dermatitis market, currently inhibited by Incyte’s approved Opzelura.
With severaIncytetiLeo Pharma in hand,JAK inhibitorJAKcluding a recent delgocitinibl pitting the candidate against theatopic dermatitis-of-care, Leo says its delgocitiIncytes growth driOpzelurantial.
Now, the drugmaker will be “investing additional resources in accelerating the launch of this potential treatment to patients,” Leo said in its fdelgocitinib earnings release.
The cream is currently under regulatory review in Europe. As for other markets including the U.S., Leo is “assessing ways” to bring the potential treatment to commercialization, it said.
Delgocitinib has been marked in Japan by Japan Tobacco for four years now.
Delgocitinibce supporting the drug includes two phase 3 studies against a placebo cream and an open-label extension study proving its success in treating patients with moderate-to-severe chronic hand eczema.
Most recently, delgocitinib went up against standard-of-care alitretinoin capsules, the only currently approved treatment for chronic hand eczema patients who do not respond to topical cochronic hand eczema
In the DELTA FOdelgocitinib 513 patients, Leo’s candidate proalitretinoinor reduction in scoring on the Hand Eczema Severity Ichronic hand eczema week 24. It also trumped alitretinoin in two other secondary measures assessing treatment success and quality of life.
“We are confident that with the DELTA FORCE study, delgocitinib cream may play a crucial role in expandiHand Eczemaons available for patients in this hard-to-treat conditialitretinoinevelopment officer Kreesten Meldgaard Madsen said at the time.
If the drug scores approval, it would compete with delgocitiniber marketed topical JAK inhibitor, Incyte’s Opzelura.
That med is a cream version of the company’s popular JAK inhibitor Jakafi. Other thJAK inhibitorJAKatopic dermaIncyte OpOpzeluras also approved to treat vitiligo.
Incyte is now moving to expand the Jakafi counterpartJAK inhibitorJAKto pediatriJakafiic dermatitisatopic dermatitistoOpzeluraits bid for the indication vitiligor along with “multiple data readouts,” head of R&D Pablo Cagnoni said on the company’s first-quarter earnings call. A pediatric nod would add some two million to three million eligible patients to the med’s reach, the company said.
Incytera and Jakafi brought Incyte Jakafickbuster fourth-qupediatric atopic dermatitisecting what the company’s North America general manager Barry Flannelly called “one of the best recent dermatology launches” on Opzelura’s part following its 2021 approval.
More recently over this yearIncytest quarter, sales for both Opzelura and Jakafi sank on a quarterly basis, missing analyst’s consensus.
While Jakafi was impacted by higher inventory drawdown and OpOpzeluray ChaJakafilathcare’s cyberattack, the explanations “still will not provide investors with data point to suggest there is upside to estimates in the near term,” analysts at William Blair wrote in a note to clients.
Opzelura pulled first-quarter revenues of $86 million, dipping 21.5% from the fourth quarter.
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