EMA committee makes positive recommendation on widening eligibility to Kaftrio to more patients in Europe, including Ireland
CFI welcomes progress that will likely widen the eligibility of innovative and ground breaking CF drug Kaftrio to more patients in Ireland. The recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the EMA now has to be approved by the European Commission. When this happens, likely in the next few weeks, this extension will come into effect in Ireland, thanks to the portfolio/pipeline agreement that was supported by CFI in 2017 as part of our Orkambi campaign.
CFI particularly notes in today's press release from Vertex:
“Today’s opinion is an important step towards bringing the medicine to any patient with at least one F508del mutation, including those with a gating or residual function mutation who were not previously eligible for the triple combination therapy,”
Since 2017, eligible patients with CF in Ireland have had access to Vertex medicines via the long-term reimbursement agreement that was developed with the Health Service Executive (HSE) and Irish Government.
As a result, if approved, people living with CF in Ireland ages 12 and older who have one copy of the F508del mutation and a gating (F/G) or residual function (F/RF) mutation will be among some of the first in Europe to be granted reimbursed access to the medicine.
In Europe, the medicine is currently licensed for the treatment of people with CF ages 12 years and older with an F/F or F/MF genotype.