After rejecting the drug in 2017, the FDA approved the 2 mg dose of baricitinib (Olumiant) for adults with moderate to severe rheumatoid arthritis.
After rejecting baricitinib (Olumiant, Eli Lilly) in 2017, the US Food and Drug Administration (FDA) approved the treatment for adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.
Baricitinib is approved for use as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs.
"We are pleased to provide RA patients in the US an effective treatment option with Olumiant, as people with RA who have had an inadequate response to TNF inhibitors are generally considered to be some of the most difficult to treat RA patients," said Christi Shaw, president, Lilly Bio-Medicines in a statement.
The baricitinib approval is based on data from the double-blind, placebo-controlled RA-BEACON study, which included 527 patients with an inadequate response or intolerance to at least one TNF inhibitor therapy. Patients were randomly assigned to receive baricitinib 2 mg, 4 mg, or placebo. Patients continued to receive the conventional DMARDs they were already taking.
The primary endpoint was the American College of Rheumatology 20% (ACR20) response measured at week 12. The study reported significantly higher rates of ACR20 response in baricitinib-treated patients compared to placebo-treated patients (55% for baricitinib 4 mg, 49% for baricitinib 2 mg, 27% for placebo).
Earlier this year, an FDA advisory committee recommended the 2 mg dose of baricitinib over the 4 mg dose. The committee supported the efficacy of the higher dose, but voted 10-5 to support the lower dose for safety and benefit-risk reasons.
The approval includes a Boxed Warning for the risk of serious infections, malignancies, and thrombosis. These risks include tuberculosis, fungal, and bacterial infections, lymphoma, deep venous thrombosis, pulmonary embolism, and arterial thrombosis. The most common adverse events (≥1% in patients treated with baricitinib 2 mg and 4 mg in placebo-controlled trials) were upper respiratory tract infections, nausea, herpes simplex and herpes zoster.
"In my clinical practice, I continue to see patients who experience debilitating symptoms and who are waiting for a medicine that may be right for them," said Elizabeth L. Perkins, MD, Rheumatology Care Center, Birmingham, Alabama. "Olumiant is an important option for rheumatologists to help address these patients' unmet needs."
As part of the FDA approval, Lilly and Incyte agreed to conduct a randomized controlled clinical trial to test the long-term safety of baricitinib in patients with rheumatoid arthritis.
"RA patients continue to experience unique challenges accessing the treatments prescribed by their healthcare providers. Therefore, we are determined to continue our work with stakeholders to demonstrate value across the healthcare system so providers have greater choice in prescribing treatments to fit individual patient needs," said Shaw.
Lilly expects to launch baricitinib in the US by the end of the second quarter of 2018, adding to the over 40 countries where it is currently approved and used.