Incyte INCY announced that the European Commission (EC) approved the novel cream formulation of JAK1/JAK2 inhibitor ruxolitinib (15 mg/g), Opzelura, for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
The EC approval was based on data from two pivotal phase III studies (TRuE-V1 [NCT04052425] and TRuE-V2 [NCT04057573]), evaluating the efficacy and the safety of Opzelura versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older. Results from the TRuE-V program showed that treatment with Opzelura led to significant improvements in facial and total body repigmentation versus vehicle.
EC’s approval was on the cards, as the European Medicines Agency’s Committee for Medicinal Products for Human Use had earlier given a positive opinion on the same.
Opzelura is already approved in the United States for the topical treatment of non-segmental vitiligo in patients 12 years of age and older, and for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
It has been a roller coaster ride for Incyte so far this year. Shares of the company are down 9.6% in the year so far compared with the industry’s decline of 6.4%.
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The initial uptake of Opzelura has been strong and approval in additional geographies will propel sales.
Ruxolitinib is approved under the brand name Jakafi for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant to hydroxyurea. It is also approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF. The drug is also approved in the United States for the treatment of steroid-refractory acute GVHD in adult and pediatric patients aged 12 years or older.
Last month, Incyte announced new data from a phase IIb clinical study evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. Data showed that patients treated with povorcitinib experienced improvements in total body and facial repigmentation.
Incyte suffered a setback last month after the company announced that the FDA issued a complete response letter (CRL) for ruxolitinib extended-release (XR) tablets for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).
Incyte also decided to discontinue the phase III LIMBER-304 trial following the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC). This indicated that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. The recommendation to stop the study was not due to safety.
The study evaluated the efficacy and safety of parsaclisib plus Jakafi versus placebo plus Jakafi in adult (age ≥18 years) patients living with myelofibrosis (MF) who have an inadequate response to Jakafi monotherapy.
On a positive note, the FDA approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
Approval of additional drugs will add an incremental stream of revenues to the top line and reduce the company’s dependence on Jakafi. Incyte has a collaboration agreement with Swiss pharma giant Novartis NVS for Jakafi.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
Zacks Rank and Stocks to Consider
Incyte currently carries a Zacks Rank #4 (Sell).
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.43 to $4.52. Estimates for 2024 have increased 7 cents to $5.26. NVO sports a Zacks Rank #1 (Strong Buy) at present.
Ligand’s earnings per share estimates for 2023 increased to $4.15 from $3.30 in the past 60 days. LGND beat earnings estimates in one of the last four reported quarters. LGND flaunts a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
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