Articles related to DEVICE/DRUG APPROVALS

Linzess is the first treatment approved for IBS-C in pediatric patients. Patients younger than 2 years can be at risk of serious dehydration and should not take Linzess for any indication.

Findings from both trials showed treatment with elinzanetant led to a statistically significant reduction (≥2 hot flashes over 24 hours) in the frequency of moderate to severe VMS compared with placebo at both 4 and 12 weeks across OASIS 1 and 2 studies.

The approval was supported by data from two phase 3 trials demonstrating improvement in near vision within 30 minutes after administration lasting up to 10 hours.

The responder rate, defined as the percentage of patients who improved by 2 stages (ie, from severe to mild adhesions, or from severe to no adhesions, or from moderate to no adhesions) was also significantly higher in the Womed Leaf group vs the control group.

This updated indication now allows the use of upadacitinib prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least 1 approved systemic therapy.

“Subcutaneous administration offers substantial workflow advantages. It can decrease chair time, reduce dependency on central lines, and allow for faster patient turnover.” – Dr. Aakash Desai