{"id":6179,"date":"2019-10-18T13:36:08","date_gmt":"2019-10-18T08:06:08","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=6179"},"modified":"2023-10-16T11:57:07","modified_gmt":"2023-10-16T06:27:07","slug":"incyte-submits-positive-results-trials-for-ruxolitinib-in-gvhd","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/incyte-submits-positive-results-trials-for-ruxolitinib-in-gvhd","title":{"rendered":"Incyte Corporation submits positive results of trials for its drug Ruxolitinib in GvHD"},"content":{"rendered":"\n

Incyte Corporation has recently announced the results of Novartis-sponsored Phase III clinical trials REACH2 evaluating its candidate Ruxolitinib (Jakafi) in patients suffering from steroid-refractory acute graft-versus-host disease (GvHD).
Graft versus host disease (GvHD), <\/a>as defined by the National Cancer Institute (NCI), is a disease in which cells from a donated stem cell graft attack the normal tissues of the receiver patient. <\/p>\n\n\n\n

The trials showed a consistent safety profile of ruxolitinib. The drug is an FDA-approved first-in-class JAK1\/JAK2 inhibitor indicated for the treatment of polycythemia vera (PV), myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF along with GvHD. <\/p>\n\n\n\n

Ruxolitinib, an orally administered small molecule, inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2. The US FDA has already granted a Breakthrough designation to the drug in the year 2016. <\/p>\n\n\n\n

Moreover, the company is also running trials for another of its drug Itacitinib, which is again an orally administered small molecule inhibiting Janus Associated Kinases 1 (JAK 1) for the acute GVHD patients who are treatment na\u00efve. The drug is currently in Phase III of the clinical trial.<\/p>\n\n\n\n

Marketed under the name Jakafi, the\ndrug is a registered trademark of Incyte Corporation in the US, and of Novartis\noutside the US. <\/p>\n\n\n\n

Graft versus host disease\nEpidemiology <\/strong><\/h4>\n\n\n\n

As per DelveInsight estimates, incident Cases of HSCTs<\/a> and first allogeneic HSCTs will significantly increase during the period 2017-2028, in 7 MM.<\/p>\n\n\n\n

DelveInsight also estimates a higher incidence of HSCTs in the United States among 7MM.<\/p>\n\n\n\n

Graft versus Host Disease Therapeutic market<\/a> in the 7MM is expected to increase in the coming years. The United States accounted for the highest GvHD market size in 2016, occupying approximately 67% of the total market. On the other hand, Spain accounted for the least market share (3%) among the 7MM countries.<\/p>\n\n\n\n

Off-label therapies dominate\nthe GvHD therapy market <\/strong><\/h4>\n\n\n\n

The lack of drug for the treatment of GvHD is the primary unmet need in the GvHD Market.<\/p>\n\n\n\n

The off-label therapies used in\nprevention and GvHD treatment are broadly classified into Corticosteroids (methylprednisolone\nand prednisolone), Calcineurin inhibitors (Cyclosporine), ATG therapies\n(Grafalon), IL2R\u03b1 (CD25) inhibitors (Simulect), TNF\u03b1 inhibitors (Remicade and\nEnbrel), Co-stimulatory blockers (Orencia and Nulojix), Calcineurin inhibitors\n(Cyclosporine), mTOR inhibitors (Rapamune and Certican), SOT therapies (CellCept\/Myfortic\nand Prograf), Anti-neoplastic therapies (Velcade, Gleevec, Methotrexate, Nipent\nand Cyclophosphamide), Stem Cell Treatments (remestemcel-L) and other biologics\n(Lemtrada and Rituxan\/MabThera).<\/p>\n\n\n\n

GvHD Prophylaxis market of the\nUnited States is built up mostly through the use of off-label drugs such as Cyclosporine,\nMethotrexate, Rapamune (sirolimus), Certican (everolimus), CellCept\/Myfortic (mycophenolate\nmofetil), Prograf (tacrolimus), Orencia (abatacept), Velcade (bortezomib),\nNulojix(belatacept) and Grafalon (Atege-Fresenius).<\/p>\n\n\n\n

The GvHD therapies market size is\nexpected to experience steady growth throughout the study period [2017-2028],\nowing to extensive pipeline research in the treatment of GvHD, emerging GvHD\ntherapies, increasing incidence, and awareness of the disease will fuel the\ngrowth of the market.<\/p>\n\n\n\n

Among the different class of\naforementioned off-label therapies, Cyclosporine is the most preferred therapy\nin the Graft versus Host Disease prophylaxis, followed by Methotrexate,\nSirolimus and Tacrolimus. <\/p>\n\n\n\n

Graft versus host disease Pipeline\n<\/strong><\/h4>\n\n\n\n

Expected launch of potential\ntherapies on the similar lines of Ruxolitinib (Incyte Corportaion\/Novartis)\nsuch as Itacitinib  candidate of Incyte\nCorporation and Uvadex (methoxsalen) a drug of Mallinckrodt Pharmaceuticals are\nunder simulations for acute GvHD treatment may increase the market size in the\ncoming years, assisted by an increase in the incidence of Hematopoietic stem\ncell transplantation (HSCT).<\/p>\n\n\n\n

Along with above-mentioned therapies other drugs such as Leukotac (Elsalys Biotech), KD025 (Kadmon Corporation), Glassia (Kamada) etc. are also expected to launch in the coming years.<\/p>\n","protected":false},"excerpt":{"rendered":"

Incyte Corporation has recently announced the results of Novartis-sponsored Phase III clinical trials REACH2 evaluating its candidate Ruxolitinib (Jakafi) in patients suffering from steroid-refractory acute graft-versus-host disease (GvHD). Graft versus host disease (GvHD), as defined by the National Cancer Institute (NCI), is a disease in which cells from a donated stem cell graft attack the […]<\/p>\n","protected":false},"author":1,"featured_media":6185,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[41],"tags":[6601,17802,6600,17776,2629,6603],"industry":[17225],"therapeutic_areas":[17227],"class_list":["post-6179","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-snippets","tag-graft-versus-host-disease-4","tag-graft-versus-host-disease-pipeline","tag-graft-versus-host-disease-market","tag-gvhd","tag-incyte-corporation","tag-ruxolitinib","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders"],"acf":[],"yoast_head":"\nIncyte Corporation submits positive results of trials for its 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