Orladeyo (berotralstat) / BioCryst 
Welcome,         Profile    Billing    Logout  
 2 Diseases   5 Trials   5 Trials   221 News 


123»
  • ||||||||||  Takhzyro (lanadelumab-flyo) / Takeda, Orladeyo (berotralstat) / BioCryst
    Healthcare Costs Among Commercially-Insured Patients with Hereditary Angioedema Managed with Long-Term Prophylaxis: A Retrospective US Claims Database () -  Mar 8, 2024 - Abstract #ISPOR2024ISPOR_1555;    
    These real-world findings suggest lower HCRU and health care costs among pts with HAE persistent on lanadelumab for at least 18 months than those persistent on berotralstat for at least 6 months. Given the increasing number of patients receiving non-androgen LTP and limited data on related real-world healthcare costs in the US, we estimated such costs based on a large retrospective insurance claims database Eligible commercially-insured patients from the IQVIA PharMetrics
  • ||||||||||  Takhzyro (lanadelumab-flyo) / Takeda, Orladeyo (berotralstat) / BioCryst, Firazyr (icatibant) / Takeda
    Review, Journal:  Uncovering the True Burden of Hereditary Angioedema due to C1-Inhibitor Deficiency: A Focus on the Asia-Pacific Region. (Pubmed Central) -  Jan 8, 2024   
    Suggestions are provided for improving the time to diagnosis in the region, increasing access to guideline-recommended treatments, and providing support to reduce the burden on patients and caregivers. There is an urgent need to improve HAE services and provide access to life-saving treatment in developing countries, and efforts should be made to increase awareness of guideline recommendations in high-income economies that do not currently provide long-term prophylactic treatments.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst
    Berotralstat Reduced Attack Rates In Patients With Suspected Bradykinin-Mediated Angioedema: Real-World Outcomes (Monitor 13) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_898;    
    Long-term HAE prophylaxis with berotralstat led to a sustained reduction in attacks compared to patients Median attack rate was reduced to 1.0 attack (0.50, 2.50) per month (n=277) through the first 90 days after starting berotralstat therapy, and remained below baseline with median monthly attack rates of 1.0 (0.33, 2.75) from Days 91
  • ||||||||||  Orladeyo (berotralstat) / BioCryst
    Berotralstat Improved Quality of Life through 96 Weeks Across Multiple Subgroups of Patients with Hereditary Angioedema (Convention Center, Lobby Level, Hall 2) -  Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1957;    
    P3
    We are hoping that future clinical studies, registries, and databases will shed additional light on this subject. Long-term prophylaxis with berotralstat led to sustained and clinically meaningful improvements in patient-reported QoL across multiple subgroups, suggesting sustained reductions in disease and treatment burden.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst
    Real-World Outcomes in Patients with Hereditary Angioedema (HAE) Treated with Berotralstat (Convention Center, Lobby Level, Hall 2) -  Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1448;    
    These final results from APeX-S support the long-term safety and efficacy of oral berotralstat, making it an effective and convenient prophylactic HAE therapy option. The majority of patients reported ?0.5 attack/month demonstrating that berotralstat is an effective and convenient long-term prophylactic treatment option for patients with HAE.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst
    Trial completion, Trial completion date, Trial primary completion date:  APeX-S: A Long Term Safety Study of BCX7353 in Hereditary Angioedema (clinicaltrials.gov) -  Jan 13, 2023   
    P2/3,  N=386, Completed, 
    Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Apr 2022 Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Apr 2022 | Trial primary completion date: Feb 2024 --> Apr 2022
  • ||||||||||  Takhzyro (lanadelumab) / Takeda, Orladeyo (berotralstat) / BioCryst
    Journal:  Consensus on diagnosis and management of Hereditary Angioedema in the Middle East: A Delphi initiative. (Pubmed Central) -  Jan 6, 2023   
    4) Attenuated androgens and tranexamic acid may be considered for long-term prophylaxis, if lanadelumab, C1-Inhibitor or berotralstat are not available. This consensus recommendation may help to educate healthcare practitioners in the Middle East and unify their approach to the diagnosis and management of HAE.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst
    Review, Journal:  A review of berotralstat for the treatment of hereditary angioedema. (Pubmed Central) -  Nov 22, 2022   
    P2, P2/3,
    It provides a comprehensive synopsis of the results of the first clinical trials with a targeted oral kallikrein inhibitor (APeX-1 [NCT02870972]; ZENITH-1 [NCT03240133]; APeX-2 [NCT03485911]; APeX-S [NCT03472040]; APeX-J [NCT03873116]), reviewing evidence on the efficacy and safety of the drug, and placing berotralstat on the spectrum of long-term prophylactic therapeutic options. The availability of the first targeted oral prophylactic drug, the kallikrein inhibitor berotralstat, in 2021, is a milestone in the treatment of patients with hereditary angioedema.
  • ||||||||||  Takhzyro (lanadelumab) / Takeda, Orladeyo (berotralstat) / BioCryst, avoralstat (BCX4161) / BioCryst
    Review, Journal:  Interventions for the long-term prevention of hereditary angioedema attacks. (Pubmed Central) -  Nov 10, 2022   
    It is possible that danazol, subcutaneous C1-INH and recombinant human C1-INH are more effective than berotralstat and lanadelumab in reducing the risk of breakthrough attacks, but the small number of studies and the small size of the studies means that the certainty of the evidence is low. This and the lack of head-to-head trials prevented us from drawing firm conclusions on the relative efficacy of the drugs.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst
    Enrollment open, Trial initiation date:  APeX-P: Berotralstat Treatment in Children With Hereditary Angioedema (clinicaltrials.gov) -  Oct 25, 2022   
    P3,  N=20, Recruiting, 
    This and the lack of head-to-head trials prevented us from drawing firm conclusions on the relative efficacy of the drugs. Not yet recruiting --> Recruiting | Initiation date: Jul 2022 --> Oct 2022
  • ||||||||||  Takhzyro (lanadelumab) / Takeda, Orladeyo (berotralstat) / BioCryst
    Matching-Adjusted Indirect Treatment Comparison Between Lanadelumab and Berotralstat for Hereditary Angioedema Prophylaxis (Exhibit Hall (Upper Concourse); Monitor 10) -  Oct 10, 2022 - Abstract #ACAAI2022ACAAI_642;    
    P3
    In a subgroup analysis that only considered patients from the HELP OLE Study who rolled over from lanadelumab 300 mg Q2W arm in the HELP Study, lanadelumab 300 mg Q2W was associated with a statistically significantly 81% lower HAE attack rate per 28 days compared with berotralstat 150 mg QD over 48 weeks of treatment (RR 0.19; 95% CI 0.12, 0.29; p<0.0001). Conclusion In this MAIC, lanadelumab 300 mg Q2W was associated with a statistically significantly lower rate of HAE attacks per 28 days versus berotralstat 150 mg QD at 48 weeks of treatment.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst
    Rapid and Sustained Reductions in Hereditary Angioedema Attack Rates with Long-term Berotralstat: Real-World Outcomes (M100-M103 (Main Concourse), Kentucky International Convention Center) -  Oct 10, 2022 - Abstract #ACAAI2022ACAAI_575;    
    The most common adverse events reported were consistent with clinical trials. Conclusions This data shows that berotralstat provided a rapid and sustained reduction in HAE attack rates within the first months of starting therapy making oral berotralstat an effective treatment option for patients with HAE.
  • ||||||||||  Review, Journal:  Treatment of hereditary angioedema-single or multiple pathways to the rescue. (Pubmed Central) -  Oct 1, 2022   
    Investigational therapies, including the activated factor XII inhibitor garadacimab and an antisense oligonucleotide targeting plasma prekallikrein messenger RNA (donidalorsen), have shown promise as long-term prophylaxis. Given the requirement of lifelong management for HAE, further research is needed to determine how best to individualize optimal treatments for each patient.
  • ||||||||||  Takhzyro (lanadelumab) / Takeda, Orladeyo (berotralstat) / BioCryst
    Journal:  Management of pediatric hereditary angioedema types 1 and 2: A search for international consensus. (Pubmed Central) -  Sep 14, 2022   
    The guidelines are shifting away from attenuated androgens and tranexamic acid for long-term prophylaxis toward medications such as subcutaneous C1 esterase inhibitor, lanadelumab, and berotralstat. Although some differences exist based on geographic region and health system where an included guideline was published, they have very minimal differences on close review.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst, Pemazyre (pemigatinib) / Incyte, Specialised Therap
    Cost-Based vs Value-Based - How Do Japan's and Germany's Pricing Frameworks Compare? (In-person; Virtual) -  Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1612;    
    Although based on a limited sample, this research suggests that CBP methods might lead to lower price points than VBP methods. Manufacturers have raised concerns about Chuikyo’s pricing framework in the past, calling for a better recognition of the added benefit of innovative products.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst, Xeljanz (tofacitinib) / Pfizer
    Review, Journal:  Small molecule drugs for atopic dermatitis, rheumatoid arthritis, and hereditary angioedema. (Pubmed Central) -  Mar 17, 2022   
    Scientific advances have led to an increase in the development of targeted SMDs for the treatment of chronic immunologic disorders, which may revolutionize the management of these diseases. Head-to-head studies and real-world evidence are needed to fully compare treatment attributes between biologics and SMDs, including safety, efficacy, adherence, impact on QoL, and cost-effectiveness.
  • ||||||||||  Orladeyo (berotralstat) / BioCryst
    Enrollment closed:  APeX-A: Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies (clinicaltrials.gov) -  Mar 17, 2022   
    P3,  N=110, Active, not recruiting, 
    Head-to-head studies and real-world evidence are needed to fully compare treatment attributes between biologics and SMDs, including safety, efficacy, adherence, impact on QoL, and cost-effectiveness. Not yet recruiting --> Active, not recruiting