Gilead Sciences Inc. (NASDAQ: GILD) has received accelerated approval from the U.S. FDA for its liver disease treatment, Livdelzi (seladelpar), following its acquisition of CymaBay Therapeutics Inc. for $4.3 billion earlier this year.
The FDA has authorized Livdelzi for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have not adequately responded to UDCA, or as a monotherapy for those who are intolerant to UDCA. However, the drug is not recommended for patients with decompensated cirrhosis.
Livdelzi enters a competitive PBC market alongside Ipsen’s Iqirvo (elafibranor), which received approval in June and is being co-developed with GENFIT (Nasdaq and Euronext: GNFT).
The FDA’s decision was based on results from the Phase III RESPONSE study, which demonstrated that 62% of participants receiving Livdelzi achieved the primary endpoint of composite biochemical response at 12 months, compared to just 20% in the placebo group. Additionally, 25% of those on Livdelzi returned to normal alkaline phosphatase (ALP) levels, a key cholestatic marker, versus 0% in the placebo cohort. It is important to note, however, that the accelerated approval was granted on the basis of ALP reduction; improvements in survival or the prevention of liver decompensation events have yet to be established, necessitating post-approval confirmatory trials.
In a related move, Gilead recently paid $320 million to Johnson & Johnson’s subsidiary, Janssen, to acquire the latter’s royalty rights on global sales of seladelpar, which had previously entitled Janssen to an 8% royalty under a prior agreement with CymaBay.- Flcube.com
