Rx Product News: May 2023

Abrocitinib (Cibinqo)

From: Pfizer Inc

The FDA has approved a supplemental new drug application to expand the indication for abrocitinib (Cibinqo; Pfizer), which now includes individuals aged 12 to 17 years with refractory, moderate to severe atopic dermatitis that is not controlled with other systemic medications or for whom those therapies are not advisable. The drug is an oral Janus kinase inhibitor intended to modulate multiple cytokines, including IL-4, IL-13, IL-22, IL-31, and thymic stromal lymphopoietin. The approval for the expanded indication was based on the phase 3 JADE TEEN clinical trial (NCT03796676), which analyzed both the 100- and 200-mg doses compared with placebo. The most common adverse events reported included headaches, nasopharyngitis, and nausea.

For More Information:

pfizer.com

FreeStyle iCGM for FreeStyle Libre 2, FreeStyle Libre 3

From: Abbott

The FDA has approved an integrated continuous glucose monitoring (iCGM) sensor system to be added to FreeStyle Libre 2 and FreeStyle Libre 3, which will be integrated with automated insulin delivery systems. Abbott plans to partner with insulin pump manufacturers Insulet and Tandem to integrate the sensors in an artificial pancreas system that will be made available in the United States and other countries. Individuals 2 years and older can wear the newly modified sensors for 15 days. The company’s other sensor, FreeStyle Libre, was approved for only 14 days of wear for individuals 4 years and older. The modified sensors can be used by women who are pregnant and have gestational, type 1, or type 2 diabetes. The product is expected to be available in late 2023.

For More Information:

abbott.com

Sarilumab (Kevzara)

From: Regeneron Pharmaceuticals Inc and Sanofi

The FDA has approved sarilumab (Kevzara; Regeneron Pharmaceuticals Inc, Sanofi) for the treatment of adults with polymyalgia rheumatica (PMR) who had an inadequate response to corticosteroids or are unable to tolerate corticosteroids tapering. Sarilumab, previously granted priority review, is a fully human monoclonal antibody that inhibits IL-6 pathways by binding and blocking the receptors that inhibit mediated signaling. It was previously approved for adults with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to 1 or more disease-modifying antirheumatic drugs. This latest approval was based on findings from the phase 3 SAPHYR trial (NCT03600818). Participants had active, steroid-resistant PMR that flared on 7.5 mg/day or greater prednisone or the equivalent during taper. The most common adverse events included constipation, fatigue, injection-site pruritus, leukopenia, myalgia, neutropenia, and pruritic rash.

For More Information:

regeneron.com

Extended-Release Deutetrabenazine (Austedo XR)

From: Teva Pharmaceutical Industries Ltd

The FDA has approved extended-release deutetrabenazine (Austedo XR; Teva Pharmaceutical Industries Ltd) as a once-daily formulation for adults with tardive dyskinesia and chorea associated with Huntington disease. Previously, deutetrabenazine was marketed as a twice-daily regimen. Deutetrabenazine is the first vesicular monoamine transporter 2 inhibitor approved for this indication. The once-daily formulation demonstrated therapeutic equivalence to the twice-daily formulation and will be available in extended-release strengths of 6, 12, and 24 mg. The drug can be taken with or without food. Adverse events include a possible worsening in cognition, functional capacity, mood, and rigidity.

For More Information:

tevapharm.com