LEO Pharma Canada finalizes LOI with pCPA for Anzupgo (delgocitinib cream) in chronic hand eczema
核心洞察
LEO Pharma Canada and the pan-Canadian Pharmaceutical Alliance (搜索) concluded negotiations with a signed Letter of Intent for Anzupgo (delgocitinib cream), a step toward public reimbursement.
Anzupgo is the first topical treatment specifically indicated for adults with moderate to severe chronic hand eczema (搜索) when topical corticosteroids are inadequate or not advisable.
The filing rests on the Phase III DELTA program, including pivotal DELTA 1 and DELTA 2 and the DELTA FORCE study versus oral alitretinoin over 24 weeks.
LEO Pharma Canada has completed negotiations with the pan-Canadian Pharmaceutical Alliance (搜索) (pCPA) for Anzupgo (delgocitinib cream), resulting in a signed Letter of Intent. The company describes the agreement as an important milestone toward public reimbursement for adults with moderate to severe chronic hand eczema (搜索) (CHE) whose disease is inadequately controlled with topical corticosteroids, or for whom those treatments are not advisable. LEO Pharma added that it will work with public drug plans and with INESSS (搜索) in Quebec to support access for eligible patients across Canada.
Anzupgo is the first topical treatment specifically indicated for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or not advisable. The submission is supported by the Phase III DELTA clinical program, including the pivotal DELTA 1 and DELTA 2 studies. In the DELTA FORCE study, the cream showed superiority in efficacy and a more favourable safety profile compared with standard of care oral alitretinoin over 24 weeks. Approximately 17% of patients enrolled across the adult DELTA program were Canadian.
CHE can have a significant impact on quality of life, daily functioning and employment, a burden the company notes is felt acutely by healthcare professionals who wash their hands frequently, wear gloves and work with irritants.