A prominent consumer watchdog group is warning about the potential side effects of an experimental arthritis drug being considered by federal regulators, indicating that it poses life-threatening risks, yet offers no unique benefits over other available drugs.
On April 23, Public Citizen submitted testimony to the FDA Arthritis Advisory Committee, urging it to recommend that the agency reject approval of an Eli Lilly drug, baricitinib, which has been introduced as a potential new rheumatoid arthritis treatment.
Director of Public Citizen’s Health Research Group, Dr. Michael Carome, told the committee that the use of baricitinib for arthritis medications lacks any unique benefit over the already FDA-approved medications containing tofacitinib. However, the committee voted 14-1 to recommend approval for a 2mg dose version of the drug. It voted 9-6 that the safety information supported approval of a dose at that size. The committee voted 10-5 against recommending approval of a stronger 4 mg dose, however.
While the FDA advisory committee’s decisions are not binding, the agency often follows the recommendations when deciding whether to approve new medications.
Baricitinib was developed by both Incyte and Eli Lilly to act as an inhibitor of janus kinase, blocking the subtypes JAK1 and JAK2. Eli Lilly first introduced baricitinib as a possible arthritis treatment to the FDA in April 2017. However, agency reviewers determined it had an unfavorable risk-benefit profile.
Randomly selected clinical trials showed that baricitinib may cause potentially fatal blood clots in patients, which is a risk not seen in similar rheumatoid arthritis medications.
Data from clinical trials also led FDA reviewers to determine that a 4mg daily dose of baricitinib seems to offer only limited improvement over a lower 2mg dose. However, the larger dose raises the risk of safety issues such as pulmonary embolism and deep vein thrombosis.
Despite the FDA’s 2017 rejection, Eli Lilly resubmitted an application for approval without any new data proving the medication would not pose blood clotting risks to users, Public Citizen indicates.
Public Citizen presented findings from four pivotal randomized controlled trials which found inconsistent separations of efficacy outcomes between 2 mg and 4 mg doses. The group’s researchers also reported that side effects of the drug could range from malignancies, sustained decreased neutrophil count, opportunistic infections, tuberculosis, Herpes zoster infections and gastrointestinal perforation.
However, the group’s greatest concern was over the links to blood clot-related injuries.
“Given the available data, the only reasonable course of action for this committee and the FDA is to reject approval of the NDA for baricitinib,” Carome testified. “FDA approval, with reliance on warnings in the product labeling and postmarket pharmacovigilance, would be a reckless approach and would not be in the
interests of public health.”