MILAN (ITALPRESS) – Gilead Sciences announces the admission of reimbursement by the Italian Agency for Pharmaco (AIFA) of seladelpar for the treatment of Colangitis Biliare Primitiva (Primary Biliary Cholangitis, PBC) in combination with ursodesoxylic acid (UDCA) in adults who have an inadequate response to UDCA alone or monotherapy. PBC is a chronic autoimmune and cholestatic liver disease that mainly affects women between 45 and 65 years. In Italy, the prevalence of the PBC is estimated in 27,9 cases per 100 thousand inhabitants, with an annual incidence of 5,31 cases every 100 thousand inhabitants. The disease can progressively evolve towards advanced fibrosis, cirrhosis, until liver transplantation is necessary. The most common symptoms are chronic fatigue and itching; the latter is particularly difficult to treat so much as to deeply compromise the quality of life, interfering with sleep, psychological well-being, working life and daily activities. Currently there is no cure for Primitive Biliar Colangitis and treatments aim to slow the progression of the disease and reduce the symptoms related to cholestasis, such as itching. The effectiveness of the treatment is mainly measured with the improvement of liver biochemical tests, including the normalization of alkaline phosphate levels (ALP), an important marker of progression of the disease in Primitive Biliare Colangitis.
Despite the consolidated use of ursodesoxylic acid (UDCA) as first-line therapy, a proportion of patients does not reach the desired biochemical response, resulting in an increased risk of progression of the disease. The results of Phase 3 RESPONSE study showed that 62% of participants taking seladelpar reached the primary endpoint of composite biochemical response per month 12, compared to 20% of participants taking placebo. Seladelpar treatment has led to the normalization of alkaline phosphatease levels (ALP) in 25% of the study participants a month 12, a highly predictive parameter of long-term outcomes in the PBC. This variation was not observed in any of the participants in the study taking placebo. Patients treated with seladelpar also demonstrated a statistically significant reduction in itching compared to placebo. After six months of treatment with seladelpar, participants who started the study with itching from moderate to severe found an improvement of 3.2 points on a numerical assessment scale of itching from 0 to 10, a clinically significant improvement, compared to a decrease of 1.7 points with the placebo. Security data show a favourable profile and good tolerance, with a low incidence of adverse events.
“This important result is a further step towards a paradigm shift in the management of the Primitive Biliare Colangitis,” says Carmen Piccolo, Executive Country Medical Director of Gilead Sciences. “It is not only about the biochemical parameters, but of having a concrete focus on the quality of life of patients. With this goal we confirm our commitment to the area of liver disease, where we have been at the forefront for years: a commitment that has contributed to change history in the management of viral hepatitis and that we hope can make a difference also in the Primitive Biliare Colangitis. Today, with the arrival of seladelpar, we confirm once again the spirit with which Gilead addresses the challenges: developing solutions that transform people’s lives.”.
– photo IPA Agency –
(ITALPRESS).
