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Incyte (INCY) Banks on Opzelura as Jakafi Faces Competition
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Incyte’s (INCY - Free Report) performance in 2023 was tepid as pipeline setbacks and competition for lead drug Jakafi weighed on shares.
Lead drug Jakafi (ruxolitinib) posted 8% growth in sales in the first three quarters of 2023.
However, the FDA approval of GSK plc’s (GSK - Free Report) momelotinib, under the brand name Ojjaara, for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythaemia), in adults with anemia, posed a concern.
Ojjaara is a once-a-day oral JAK1/JAK2 and activin A receptor type 1 inhibitor.
Incyte’s Jakafi, a first-in-class JAK1/JAK2 inhibitor, is also approved for myelofibrosis. The approval of another JAK1/JAK2 inhibitor for the same indication will pose competition for Jakafi, particularly given Ojjaara’s comprehensive labeling.
Ojjaara is approved for newly diagnosed and previously treated myelofibrosis patients with anemia that addresses the critical manifestations of the disease, namely anemia, constitutional symptoms and splenomegaly.
Incyte has a collaboration agreement with Swiss pharma giant Novartis (NVS - Free Report) for Jakafi.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
Earlier, Incyte suffered a setback when the FDA issued a complete response letter (“CRL”) for ruxolitinib extended-release tablets for once-daily use in the treatment of certain types of myelofibrosis, polycythemia vera and graft-versus-host disease.
The CRL stated that the FDA could not approve the new drug application (“NDA”) in its present form. The regulatory body acknowledged that the study submitted to the NDA met its objective of bioequivalence based on the area under the curve parameters but identified additional requirements for approval.
Incyte also discontinued the phase III LIMBER-304 trial, which evaluated the efficacy and safety of parsaclisib plus Jakafi versus placebo plus Jakafi in adult (age ≥18 years) patients with myelofibrosis who have an inadequate response to Jakafi monotherapy. The trial was discontinued following the results of a pre-planned interim analysis conducted by an independent data monitoring committee, indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.
Nevertheless, the strong uptake of Opzelura (ruxolitinib) cream in atopic dermatitis (AD) and vitiligo in the United States propelled the company to post 9% revenue growth in the first three quarters.
Opzelura's solid uptake is being driven by patient demand growth and payer coverage expansion as the launch in AD and vitiligo continues. Opzelura was also approved in Europe for treating nonsegmental vitiligo with facial involvement. Moreover, three phase II studies in lichen planus, lichen sclerosus and mild to moderate hidradenitis suppurativa have completed enrollment. Two phase III trials evaluating ruxolitinib cream in prurigo nodularis are ongoing.
In addition, Incyte announced encouraging results from the phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura in children (age ≥2 to <12 years) with AD. A potential label expansion in this population will boost sales.
Incyte is also evaluating povorcitinib, an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. 52-week data from a phase IIb study evaluating the safety and efficacy of povorcitinib showed that treatment with oral povorcitinib was associated with substantial total body and facial repigmentation across all treatment groups at week 52 and further reinforces the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive nonsegmental vitiligo.
The phase II, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of povorcitinib in participants with prurigo nodularis (“PN”) met its primary endpoint. A phase III study in PN is being planned.
Earlier, the FDA also approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for treating adults with metastatic or recurrent locally advanced merkel cell carcinoma.
Incyte has collaborated with Syndax for the development and commercialization of axatilimab, an anti-CSF-1R antibody; the biologics license application for axatilimab in adult and pediatric patients six years or older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy was submitted to the FDA on Dec 28, 2023. An approval is anticipated in 2024.
Approval of additional drugs will add incremental revenues to the top line and reduce the company’s dependence on Jakafi.
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Incyte (INCY) Banks on Opzelura as Jakafi Faces Competition
Incyte’s (INCY - Free Report) performance in 2023 was tepid as pipeline setbacks and competition for lead drug Jakafi weighed on shares.
Lead drug Jakafi (ruxolitinib) posted 8% growth in sales in the first three quarters of 2023.
However, the FDA approval of GSK plc’s (GSK - Free Report) momelotinib, under the brand name Ojjaara, for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythaemia), in adults with anemia, posed a concern.
Ojjaara is a once-a-day oral JAK1/JAK2 and activin A receptor type 1 inhibitor.
Incyte’s Jakafi, a first-in-class JAK1/JAK2 inhibitor, is also approved for myelofibrosis. The approval of another JAK1/JAK2 inhibitor for the same indication will pose competition for Jakafi, particularly given Ojjaara’s comprehensive labeling.
Ojjaara is approved for newly diagnosed and previously treated myelofibrosis patients with anemia that addresses the critical manifestations of the disease, namely anemia, constitutional symptoms and splenomegaly.
Incyte has a collaboration agreement with Swiss pharma giant Novartis (NVS - Free Report) for Jakafi.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
Earlier, Incyte suffered a setback when the FDA issued a complete response letter (“CRL”) for ruxolitinib extended-release tablets for once-daily use in the treatment of certain types of myelofibrosis, polycythemia vera and graft-versus-host disease.
The CRL stated that the FDA could not approve the new drug application (“NDA”) in its present form. The regulatory body acknowledged that the study submitted to the NDA met its objective of bioequivalence based on the area under the curve parameters but identified additional requirements for approval.
Incyte also discontinued the phase III LIMBER-304 trial, which evaluated the efficacy and safety of parsaclisib plus Jakafi versus placebo plus Jakafi in adult (age ≥18 years) patients with myelofibrosis who have an inadequate response to Jakafi monotherapy. The trial was discontinued following the results of a pre-planned interim analysis conducted by an independent data monitoring committee, indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.
Nevertheless, the strong uptake of Opzelura (ruxolitinib) cream in atopic dermatitis (AD) and vitiligo in the United States propelled the company to post 9% revenue growth in the first three quarters.
Opzelura's solid uptake is being driven by patient demand growth and payer coverage expansion as the launch in AD and vitiligo continues. Opzelura was also approved in Europe for treating nonsegmental vitiligo with facial involvement. Moreover, three phase II studies in lichen planus, lichen sclerosus and mild to moderate hidradenitis suppurativa have completed enrollment. Two phase III trials evaluating ruxolitinib cream in prurigo nodularis are ongoing.
In addition, Incyte announced encouraging results from the phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura in children (age ≥2 to <12 years) with AD. A potential label expansion in this population will boost sales.
Incyte is also evaluating povorcitinib, an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. 52-week data from a phase IIb study evaluating the safety and efficacy of povorcitinib showed that treatment with oral povorcitinib was associated with substantial total body and facial repigmentation across all treatment groups at week 52 and further reinforces the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive nonsegmental vitiligo.
The phase II, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of povorcitinib in participants with prurigo nodularis (“PN”) met its primary endpoint. A phase III study in PN is being planned.
Earlier, the FDA also approved Zynyz (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for treating adults with metastatic or recurrent locally advanced merkel cell carcinoma.
Incyte has collaborated with Syndax for the development and commercialization of axatilimab, an anti-CSF-1R antibody; the biologics license application for axatilimab in adult and pediatric patients six years or older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy was submitted to the FDA on Dec 28, 2023. An approval is anticipated in 2024.
Approval of additional drugs will add incremental revenues to the top line and reduce the company’s dependence on Jakafi.