Delving into the Latest Updates on Follitropin alfa biosimilar(Cinnagen) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Cinnal-F, Follitropin alfa biosimilar, rec Hu-FSH

Target

FSHR

Mechanism

FSHR agonists(Follicle-stimulating hormone receptor agonists)

Therapeutic Areas

Urogenital Diseases

Active Indication

Infertility

Inactive Indication-

Originator Organization

CinnaGen Co.

Active Organization

CinnaGen Co.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 3246

The sequence is quoted from: *****

Sequence Code 3253

The sequence is quoted from: *****

BackgroundSurgical site complication (SSC) rates in breast surgery have been reported between 2.25% and 53%. Use of incision management may help reduce the risk of SSCs. The potential of 2 closed incision negative pressure therapy (ciNPT) systems to mitigate surgical site complications (SSC) and surgical site infections (SSI) in breast surgery were assessed.MethodsA systematic literature review for breast surgery studies was conducted comparing ciNPT use against standard of care (SOC). SSC, SSI, and dehiscence rates were examined. SSCs were defined as all surgical site complications including SSI, dehiscence, seroma, hematoma, and necrosis. Risk ratios and random effects models were used to assess the effect of ciNPT with multilayer absorbent dressing (ciNPT-MLA) and ciNPT with foam dressing (ciNPT-F) compared with SOC.ResultsEight articles were included in the meta-analysis. No significant differences in SSC rates (P = .307) or SSI rates (P = .453) between ciNPT-MLA and SOC were observed. ciNPT-MLA use was associated with a reduction in dehiscence compared with SOC (RR = 0.499, 95% CI = 0.303, 0.822; P = .006). A significant reduction in SSC rates (RR = 0.498, 95% CI = 0.271, 0.917; P = .025) was observed with ciNPT-F use. Similarly, dehiscence rate reduction was associated with ciNPT-F use (RR = 0.349, 95% CI= 0.168, 0.725; P = .005). A trend towards reduction of SSI rates with ciNPT-F use compared with SOC was also noted (P = .053).ConclusionsCompared with SOC, ciNPT-MLA significantly reduced rates of dehiscence, while ciNPT-F use resulted in significantly reduced SSC and dehiscence rates with a trend toward reducing SSI.

20 Jun 2023·Cureus

Outcomes of Two Different Negative Pressure Therapy Systems for Closed Incision Management in Knee and Hip Arthroplasty: A Systematic Review and Meta-Analysis

Review

Author: Griffin, Leah P ; Cooper, H John ; Bongards, Christine ; Silverman, Ronald

Closed incision negative pressure therapy (ciNPT) has been adopted into practices of diverse surgical specialties to help reduce postsurgical complication risks. There are two primary commercially available systems that deliver ciNPT through different mechanisms. The purpose of this meta-analysis is to compare the potential effects of two different ciNPT systems on clinical outcomes following hip and knee arthroplasty. A systematic literature search was conducted to identify hip and knee arthroplasty studies comparing the incidence of surgical site infections (SSIs) and surgical site complications (SSCs) versus standard of care (SOC) following the use of two different ciNPT systems. Four meta-analyses were performed by calculating risk ratios (RR) to assess the effect of (1) ciNPT with foam dressing (ciNPT-F) versus SOC and (2) ciNPT with multilayer absorbent dressing (ciNPT-MLA) versus SOC. Comprehensive Meta-Analysis Version 3.0 (Biostat Inc., Englewood, NJ) software was used to perform the analyses. Twelve studies comparing ciNPT-F to SOC and six studies comparing ciNPT-MLAto SOC were analyzed. SSI rates were reported in seven of 12 studies involving ciNPT-F. In those, ciNPT-F significantly reduced the incidence of SSI (RR = .401, 95% confidence interval (CI) = .190, .844; p = .016). Across four of six studies that reported SSI rates, there was no significant difference in SSI rates between ciNPT-MLAvs SOC (RR = .580, 95% CI = .222, 1.513; p = .265). SSC rates were evaluated in eight of 12 ciNPT-F studies that reported SSC rates. This meta-analysis of the eight ciNPT-F studies showed significantly reduced SSC rates with ciNPT-F vs SOC (RR = .332, 95% CI = .236, .467; p < 0.001). For ciNPT-MLA, five of six studies reported SSC rates. In those, there was no significant difference in SSC rates between ciNPT-MLA vs SOC (RR = .798, 95% CI = .458, 1.398; p = .425). These meta-analyses results showed a significant reduction in SSI and SSC rates in the ciNPT-F group vs SOC and no difference in SSI and SSC rates in the ciNPT-MLA group vs SOC. The reasons for these observed differences were not evaluated as part of this study. Future controlled clinical studies comparing outcomes between different ciNPT systems over closed orthopedic incisions would help to validate these study results.

03 Oct 2022·Gynecological Endocrinology

The LH endocrine profile in gonadotropin-releasing hormone analogue cycles

Article

Author: De Neubourg, Diane ; Janssens, Lara ; Roelant, Ella

Research question: What does the evolution of serum luteinizing hormone (LH) levels look like throughout the follicular phase of cycles in which gonadotrophins and gonadotropin-releasing hormone (GnRH) analogues in the context of ovarian stimulation for assisted reproduction technologies (ART) were used?Design: This was a retrospective, observational cohort study in a tertiary infertility clinic. 1303 patients aged between 18 and 43 years of age were included with a total of 2200 cycles for ART, using GnRH-analogues for pituitary down-regulation stimulated with human menopausal gonadotropin (hMG) or recombinant follicle stimulating hormone (rec-FSH). Follicular evolution of LH during ovarian stimulation in different treatment protocols was modeled as repeated measures.Results: LH evolution showed a significant decrease in antagonist/hMG cycles of 0.17 IU/L per day (95% CI [-0.20, -0.12]) and 0.26 IU/L per day in rec-FSH cycles (95% CI [-0.29, -0.22]). This decrease was significantly stronger in rec-FSH cycles than in hMG cycles (estimated difference of 0.09 IU/L per day, 95% CI [0.04, 0.15]). Short agonist/hMG cycles showed a significant increase in LH of 0.04 IU/L per day (95% CI [0.01, 0.08]), while the increase of 0.01 IU/L per day in cycles with rec-FSH was not significant (95% CI [-0.08, 0.10]).Conclusion: Follicular evolution of LH during controlled ovarian stimulation differs between different GnRH analogue cycles. A statistically significant decrease in LH was shown in GnRH antagonist cycles being more pronounced with rec-FSH compared to hMG. This decrease in LH in antagonist cycles and the potential impact on estradiol levels and follicle growth needs further examination.

100 Deals associated with Follitropin alfa biosimilar(Cinnagen)

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