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Lilly sticks to PBS bid despite US setback
Posted 2 May 2017
Eli Lilly says it will continue with its PBAC submission for rheumatoid arthritis drug Olumiant (baricitinib) despite the drug being turned away by the FDA.
Olumiant was listed as a major submission to the July meeting of the PBAC on the agenda released last week. It is yet to be approved by the TGA.
"In Australia, the TGA is independently reviewing Olumiant's safety and efficacy data and in a parallel process, Lilly is seeking PBS listing for Olumiant for the treatment of adults with severe active rheumatoid arthritis," a spokesperson for the company confirmed.
Last month, the FDA issued a complete response letter to the company, saying it needed to see more clinical data on Olumiant's appropriate dosing and safety before it would give the drug a green light.
The US regulatory body's response came as a surprise because it diverged from the EMA, which positively recommended Olumiant last December and approved it officially in February, making it the first JAK inhibitor to be approved in the EU.
The drug was submitted to the FDA on the back of three phase III clinical trials that looked at its efficacy in treating the condition. The decision date for the approval has been extended another three months to assess further data.
The company has since flagged its intent to resubmit the drug in the US, but delay has compromised its position in the competitive RA space. Just last week Sanofi and Regeneron resubmitted their rival RA drug, Kevzara (sarilumab), to the FDA after it was rejected last October. Meanwhile Pfizer's Xeljanz (tofacitinib) remains the only JAK inhibitor approved in the US.
Xeljanz is TGA approved and PBS listed in Australia for RA.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 2 May 2017
Eli Lilly says it will continue with its PBAC submission for rheumatoid arthritis drug Olumiant (baricitinib) despite the drug being turned away by the FDA.
Olumiant was listed as a major submission to the July meeting of the PBAC on the agenda released last week. It is yet to be approved by the TGA.
"In Australia, the TGA is independently reviewing Olumiant's safety and efficacy data and in a parallel process, Lilly is seeking PBS listing for Olumiant for the treatment of adults with severe active rheumatoid arthritis," a spokesperson for the company confirmed.
Last month, the FDA issued a complete response letter to the company, saying it needed to see more clinical data on Olumiant's appropriate dosing and safety before it would give the drug a green light.
The US regulatory body's response came as a surprise because it diverged from the EMA, which positively recommended Olumiant last December and approved it officially in February, making it the first JAK inhibitor to be approved in the EU.
The drug was submitted to the FDA on the back of three phase III clinical trials that looked at its efficacy in treating the condition. The decision date for the approval has been extended another three months to assess further data.
The company has since flagged its intent to resubmit the drug in the US, but delay has compromised its position in the competitive RA space. Just last week Sanofi and Regeneron resubmitted their rival RA drug, Kevzara (sarilumab), to the FDA after it was rejected last October. Meanwhile Pfizer's Xeljanz (tofacitinib) remains the only JAK inhibitor approved in the US.
Xeljanz is TGA approved and PBS listed in Australia for RA.
Yajun Ma
yajun.ma@lushmedia.com.au
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