FDA Approvals Roundup: Entadfi, Zynrelef, Rinvoq
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New approvals
Entadfi okayed for benign prostatic hyperplasia
Veru’s Entadfi (finasteride and tadalafil capsules) has been approved for treating urinary tract symptoms caused by benign prostatic hyperplasia (BPH), or enlarged prostate. The combination has also been shown to have less potential for adverse sexual side effects compared with finasteride monotherapy.
Approval of Entadfi was based on findings from a 26-week double-blinded, parallel-design study in which 696 men in the indicated population were randomized to receive either the Entadfi combination or placebo with finasteride. Mean unadjusted baseline symptom score was 17.1 and 17.4 for the study and placebo groups, respectively. At week 12, the primary study endpoint, the study combination demonstrated significant improvement in symptom score compared with the placebo-plus-finasteride combination (-5.2 and -3.8, respectively). Key secondary endpoints demonstrated improvement in total symptom score at week 4, the first scheduled observation (-4.0 and -2.3). The score remained lower through week 26 (-5.5 and -4.5).
New indications
Zynrelef use extended for postoperative pain in a broader group of procedures
Heron’s Zynrelef (bupivacaine and meloxicam extended-release solution) has been granted an expanded indication for treating postsurgical pain for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.
The fixed-dose combination of liposomal bupivicaine, a long-lasting local anesthetic, and low-dose meloxicam, a nonsteroidal anti-inflammatory drug, was originally approved in May 2021 for patients who had undergone bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.
Approval for the expanded indication was based on findings from three Phase 3 studies, including EPOCH1 and EPOCH 2, demonstrating Zynrelef’s superior, sustained postoperative pain relief for up to 72 hours and an associated reduced need for opioids, compared with bupivacaine solution.
Zynrelef comes with a boxed warning for risk of serious cardiovascular and gastrointestinal events.
Rinvoq nabs expanded indication for treating active psoriatic arthritis
AbbVie’s Rinvoq (upadacitinib extended-release tablets) has been granted a new indication for treating active psoriatic arthritis (PsA) in patients who have an inadequate response to, or intolerance of, one or more tumor necrosis factor (TNF) blockers. The drug improves joint pain, swelling, stiffness, and fatigue, and prevents further joint damage in patients with PsA.
The approval was supported by efficacy findings from two pivotal Phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, in patients with PsA. At week 12 in both trials, patients receiving Rinvoq achieved significantly higher ACR20 responses (71% and 57%, in SELECT-PsA 1 and SELECT-PsA 2, respectively) compared with those receiving placebo (36% and 24%). Those percentages for ARC50 were 38% and 32% for Rinvoq, compared with placebo (13% and 5%). For ARC70, they were 16% and 9% for the study drug and 2% and 1% for placebo. Patients in the treatment group also showed improvement in physical function, fatigue, and skin manifestations from baseline compared with placebo.
Rinvoq was originally approved in 2019 for treating adults with active rheumatoid arthritis who had an inadequate response to, or intolerance of, methotrexate.
The Janus kinase inhibitor comes with a boxed warning for serious infections, malignancy, and thrombosis.
Xeljanz picks up new indication for treating active ankylosing spondylitis
Pfizer’s Xeljanz/Xeljanz XR (tofacitinib) has been granted a new indication for treating active ankylosing spondylitis (AS) in adults who have an inadequate response to, or intolerance of, one or more tumor necrosis factor (TNF) blockers.
The approval of the new indication for AS was based on efficacy and safety data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in which 269 adults from the indicated population were randomized to receive Xeljanz/Xeljanz XR or placebo. The primary endpoint was to evaluate the proportion of patients who achieved an Assessment in SpondyloArthritis international Society 20 (ASAS20) response, a measure of improvement or response to treatment, at week 16. In all, by study week 16, 56.4% of study group patients and 29.4% of the placebo group achieved an ASAS20 response (20% improvement), with 40.6% and 12.5%, respectively, achieving an ASAS40 response (40% improvement).
The drug was originally approved in 2012 for treating adults with active rheumatoid arthritis with inadequate response to, or intolerance of, methotrexate.
Xeljanz/Xeljanz XR comes with a boxed warning for major adverse cardiovascular events and thrombosis.
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