Gilead turns attention to pending seladelpar decision, key data readouts
26 Apr 2024
AcquisitionPhase 3Drug ApprovalADCAccelerated Approval
Having posted a mixed bag in the first quarter, Gilead Sciences’ attention is shifting to an FDA decision later this year on its recently-acquired drug seladelpar and a number of key Phase III readouts.
Gilead closed the $4.3-billion acquisition of CymaBay Therapeutics last month, gaining seladelpar, which is currently under FDA review for the treatment of primary biliary cholangitis (PBC), with a decision expected by August 14. A marketing filing for the oral PPAR-delta agonistPPAR-delta agonist has also been submitted in Europe, where the assessment is estimated to be completed early next year.
Chief commercial officer Johanna Mercier noted that if approved, Gilead expects seladelpar to “contribute modestly” to sales this year and more meaningfully in 2025 and beyond. An FDA decision on Ipsen and Genfit’s oral PPAR-alpha/delta agonistPPAR-alpha/delta agonist elafibranor in PBC is due some three months ahead of seladelpar’s PDUFA, something that Mercier is not worried about.
“I don't think those three months make a difference. I think really, it's about best-in-class launch,” Mercier remarked. For related analysis, read KOL Views Q&A: Leading expert sizes up PPAR battle between elafibranor, seladelpar in PBC.
Sunlenca, Trodelvy readouts
Gilead is also looking ahead to results from the PURPOSE-1 study of the HIV capsid inhibitorHIV capsid inhibitor Sunlenca (lenacapavir) as pre-exposure prophylaxis in the second half of the year. Results from the trial, along with those from PURPOSE-2, are expected to support marketing applications for HIV prevention.
Other pending data readouts are expected later this half for Trodelvy (sacituzumab govitecan) from the Phase III TROPiCS-04 study in bladder cancer. Results, if positive, could support full approval of the Trop-2-directed antibody-drug conjugate in the US, having gained accelerated clearance back in 2021, and filings in other markets. Data from the late-stage ASCENT-03 trial in first-line PD-L1 negative patients with triple-negative breast cancer are also due in the second half.
More to come.
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