Dáil Éireann Debate, Tuesday - 28 April 2026
1280. Deputy Cormac Devlin asked the Minister for Health whether her Department, the HSE or the HPRA has engaged with the manufacturer of deuruxolitinib (leqselvi) regarding plans for EU submission and availability in Ireland; whether any named-patient or compassionate access requests have been received (details supplied); and if she will make a statement on the matter. [30916/26]
Amharc ar fhreagraThe medicines regulator, the Health Products Regulatory Authority (HPRA) has confirmed that an EU Centralised Procedure Marketing Authorisation Application for the evaluation of Deuruxolitinib (Leqselvi) for the treatment of alopecia areata in adults, commenced on 26th February 2026. The outcome of the procedure is expected in Q1 2027.
HPRA have advised that, to date, they have not received any named-patient or compassionate use access engagements from the manufacturer for Deuruxolitinib (Leqselvi) for the treatment of alopecia areata in adults. Compassionate access is provided directly by companies, with the agreement of a patients treating medical consultant.
The Deputy will wish to note, given the reference to HSE engagement, that this matter has also been referred to the HSE for direct response.
