FDA sends baricitinib application back for revision

 

The Food and Drug Administration will not be able to approve a new drug application for baricitinib, a Janus kinase (JAK) inhibitor for moderate to severe rheumatoid arthritis, according to a statement from manufacturer Eli Lilly.

The FDA complete response letter cited the need for additional data to determine the most appropriate doses for the once-daily oral medication and to suss out safety concerns across treatment arms.

“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate to severe RA,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”

In the recently published RA-BEAM trial, a manufacturer-sponsored, international, randomized, double-blind, phase III clinical trial involving 1,305 adults with moderate to severe active RA, 70% of patients taking baricitinib plus background therapy with methotrexate met the primary efficacy end point – the proportion of patients at week 12 who showed an ACR 20 response – compared with 40% for placebo (N Engl J Med. 2017;376:652-62).

dfulton@frontlinemedcom.com

On Twitter @denisefulton

 

The Food and Drug Administration will not be able to approve a new drug application for baricitinib, a Janus kinase (JAK) inhibitor for moderate to severe rheumatoid arthritis, according to a statement from manufacturer Eli Lilly.

The FDA complete response letter cited the need for additional data to determine the most appropriate doses for the once-daily oral medication and to suss out safety concerns across treatment arms.

“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate to severe RA,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”

In the recently published RA-BEAM trial, a manufacturer-sponsored, international, randomized, double-blind, phase III clinical trial involving 1,305 adults with moderate to severe active RA, 70% of patients taking baricitinib plus background therapy with methotrexate met the primary efficacy end point – the proportion of patients at week 12 who showed an ACR 20 response – compared with 40% for placebo (N Engl J Med. 2017;376:652-62).

dfulton@frontlinemedcom.com

On Twitter @denisefulton

 

The Food and Drug Administration will not be able to approve a new drug application for baricitinib, a Janus kinase (JAK) inhibitor for moderate to severe rheumatoid arthritis, according to a statement from manufacturer Eli Lilly.

The FDA complete response letter cited the need for additional data to determine the most appropriate doses for the once-daily oral medication and to suss out safety concerns across treatment arms.

“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate to severe RA,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”

In the recently published RA-BEAM trial, a manufacturer-sponsored, international, randomized, double-blind, phase III clinical trial involving 1,305 adults with moderate to severe active RA, 70% of patients taking baricitinib plus background therapy with methotrexate met the primary efficacy end point – the proportion of patients at week 12 who showed an ACR 20 response – compared with 40% for placebo (N Engl J Med. 2017;376:652-62).

dfulton@frontlinemedcom.com

On Twitter @denisefulton