FDA advisory committee votes against approval for NASH drug GastroTwitter
OCA, sold under the commercial name Ocaliva, was first approved in 2016 to treat primary biliary, and is prescribed at up to 10 mg per day. Intercept proposed that OCA be given in daily 25-mg doses in the treatment of precirrhotic fibrosis due to NASH.
In 2019, Intercept initially filed for a new drug application for OCA for the treatment of precirrhotic fibrosis due to NASH but were issued a Complete Response Letter after the FDA determined that the medication had an"unfavorable risk benefit-risk assessment." Intercept resubmitted an NDA for OCA in December 2022, including two 18-month analyses from a phase 3 REGENERATE study.
In the study, which included data from 931 patients, OCA 25 mg outperformed placebo in improving fibrosis with no worsening of NASH over 18 months, one of two primary endpoints of the clinical trial. The estimated risk difference ranged from 8.6 to 12.8 across different analyses, which the FDA categorized as a"modest treatment effect."
There was no significant difference between OCA 25 mg and placebo in NASH resolution with no worsening fibrosis. Both endpoints were surrogate endpoints, meaning that they were"reasonably likely to predict clinical benefit." The FDA noted that it is not known if a decrease in fibrosis stage would lead to clinically meaningful outcomes, such as reduction in liver-related events.
The committee members voted 15 to 1 to defer approval until clinical outcome data is submitted and reviewed. The FDA has set a target decision date regarding the accelerated approval of OCA for NASH for June 22, 2023.
Indonesia Berita Terbaru, Indonesia Berita utama
Similar News:Anda juga dapat membaca berita serupa dengan ini yang kami kumpulkan dari sumber berita lain.
FDA Advisory Panel Recommends RSV Vaccine for Pregnant WomenAn FDA advisory panel has recommended that the FDA approve an RSV vaccine for pregnant women. The vaccine would be given in the final trimester, with protection from RSV being passed through the placenta to the unborn baby.
Baca lebih lajut »
Graham Nash Wants ‘People to Know You Can Still Rock at 81’The legendary counterculture rock figure is back with a new album, ‘Now.’
Baca lebih lajut »
FDA advisers vote in favor of Pfizer maternal RSV vaccineAdvisers to the U.S. Food and Drug Administration voted Thursday in favor of Pfizer’s respiratory syncytial virus vaccine for pregnant people. FDA advisory...
Baca lebih lajut »
Murray proposes that insurers fully cover over-the-counter birth control if FDA approvesThe senator says getting birth control onto the shelves of your local pharmacy is a priority.
Baca lebih lajut »