Berotralstat

BioCryst Launches ORLADEYO® (berotralstat) in Italy

Retrieved on: 
Monday, February 19, 2024
European Commission, Hereditary angioedema, News, Berotralstat, HAE, Patient, BioCryst Pharmaceuticals

RESEARCH TRIANGLE PARK, N.C., Feb. 19, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA), has finalized reimbursement and recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Feb. 19, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA), has finalized reimbursement and recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older.
  • With this recommendation, HAE patients in Italy now have access to the first oral, once-daily therapy for the routine prevention of recurrent HAE attacks.
  • “The positive AIFA recommendation of ORLADEYO® (berotralstat) broadens access to modern prophylaxis in Italy and is great news for Italian clinicians and HAE patients,” said Charlie Gayer, chief commercial officer of BioCryst.
  • The AIFA decision follows European Commission (EC) marketing authorization of ORLADEYO in April 2021.

Royalty Pharma Reports Second Quarter 2023 Results

Retrieved on: 
Tuesday, August 8, 2023
Acceleration, Net, Pressure, University, Civil service commission, Astellas Pharma, Chronic lymphocytic leukemia, Vertex, Calendar, Aplastic anemia, DPP, GAAP, Leuprorelin, Sale, Ulcerative colitis, Psoriasis, Gilead, EBITDA, Acquisition, European Commission, Patient, Risk, Metastasis, Cystic fibrosis, Growth, Johnson & Johnson, California Miramar University, FDA, Sacituzumab govitecan, Regulation of tobacco by the U.S. Food and Drug Administration, Death, Food, Ivacaftor, Pfizer, Talazoparib, Bank, Video game, Music, Vaccine, Pharmaceutical industry, Real estate, Cryptocurrency, Berotralstat, Apalutamide, Nusinersen, Elexacaftor/tezacaftor/ivacaftor, Adjustment, Guselkumab, Ibrutinib

Drivers of total royalty receipts in the second quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).

Key Points: 
  • Drivers of total royalty receipts in the second quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).
  • Royalty Pharma acquired a royalty interest in Trelegy in July 2022 and began receiving royalty receipts in the third quarter of 2022.
  • During the second quarter of 2023, Royalty Pharma began repurchasing its Class A ordinary shares and repurchased approximately four million shares for $134 million.
  • The weighted-average diluted Class A ordinary shares outstanding for the second quarter of 2023 was 606 million as compared to 607 million for the first quarter of 2023.

BioCryst to Present New ORLADEYO® (berotralstat) Data at 2023 European Academy of Allergy and Clinical Immunology Congress

Retrieved on: 
Wednesday, May 31, 2023
European Academy of Allergy and Clinical Immunology, Abstract, BioCryst Pharmaceuticals, Berotralstat, Theme, Hereditary angioedema, Dermatology, Quality of life, EAACI, TPS, Rapids, RESEARCH, HAE, Poster, Patient, Adolescence, Congress, PARK, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., May 31, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals Inc (Nasdaq: BCRX) today announced that the company will present two abstracts featuring data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) congress which is being held in Hamburg, Germany from June 9 – 11, 2023.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., May 31, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals Inc (Nasdaq: BCRX) today announced that the company will present two abstracts featuring data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) congress which is being held in Hamburg, Germany from June 9 – 11, 2023.
  • BioCryst will present two posters at Thematic Poster Session (TPS) 41 - Dermatology 3, Poster Zone C on Sunday, June 11, 2023, from 12:45 – 13.45 CEST:
    Berotralstat provides sustained reduction in HAE attack rates and improvement in quality of life in adolescent patients: a subgroup analysis from APeX-S. (Poster: TP-C103)
    Rapid and sustained reductions in attack rates demonstrated with berotralstat long-term prophylaxis in patients with hereditary angioedema with normal C1 inhibitor: real-world outcomes.
  • (Poster: TP-C106)

BioCryst Presents New Long-term and Real-world Data Demonstrating Sustained Reductions in Hereditary Angioedema Attack Rates and Improvement in Quality of Life with ORLADEYO® (berotralstat)

Retrieved on: 
Friday, February 24, 2023
Well, RESEARCH, Safety, Female, Caregiver, Berotralstat, Poster, Quality of life, American Academy, Disease, American Academy of Allergy, Asthma, and Immunology, PARK, Hereditary angioedema, Teaching hospital, BioCryst Pharmaceuticals, SEM, AAAAI, Month, Division, Hematology, HAE, Composition of the human body, Male, Pharmacy, Internal medicine, Physician, Pharmaceutical industry, Medical device, Risk management, Medical imaging, Nursing, Birth control, Patient

RESEARCH TRIANGLE PARK, N.C., Feb. 24, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new data from the APeX-S and APeX-2 clinical trials which evaluated oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) demonstrating sustained reductions in attack rates and improvement in quality of life (QoL) among patients living with HAE, highlighting its profile as a well-tolerated, effective and convenient prophylactic HAE therapeutic option.

Key Points: 
  • Overall, treatment-emergent adverse events (TEAEs) reported in APeX-2 and APeX-S were mild and transient, indicating that ORLADEYO was generally well tolerated.
  • Overall, attack rates subsequently decreased upon initiation with ORLADEYO and remained consistently low through 360 days on therapy.
  • Clinically meaningful and sustained reductions in HAE attack rates were observed in patients receiving ORLADEYO 150 mg (n=287).
  • Patients experienced sustained reductions in attacks throughout treatment through 24 months, consistent with previously reported data, further supporting the long-term safety and effectiveness of ORLADEYO.

BioCryst to Present New ORLADEYO® (berotralstat) Data at 2023 American Academy of Allergy, Asthma & Immunology Annual Meeting

Retrieved on: 
Friday, February 3, 2023
Well, BioCryst Pharmaceuticals, American Academy, RESEARCH, Poster, Caregiver, American Academy of Allergy, Asthma, and Immunology, AAAAI, HAE, Quality of life, CT, Hereditary angioedema, Berotralstat, PARK, 2021 Essex County Council election, Medical imaging, Patient

RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present four abstracts featuring data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, which is being held in San Antonio, Texas, from February 24-27, 2023.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present four abstracts featuring data on oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, which is being held in San Antonio, Texas, from February 24-27, 2023.
  • “We continue to build a consistent library of evidence that showcases the value of ORLADEYO through a combination of new analyses from our long-term clinical program and real-world evidence,” said Dr. Ryan Arnold, chief medical officer of BioCryst.
  • “From new real-world evidence that further demonstrates a meaningful reduction in attack rates experienced by patients who are on ORLADEYO, to additional analyses detailing sustained improvements in patient-reported QoL, the findings that we will present at AAAAI continue to show that our oral, once-daily prophylactic therapy is making a difference for many patients living with HAE.”
    The four abstracts that BioCryst will present are:
    Disease and Treatment Burden of Hereditary Angioedema (HAE) in Pediatric Patients: Assessment by Caregivers; Poster #417; Sunday, February 26, 9:45-10:45 am CT
    Long-term HAE Prophylaxis with Berotralstat Is Well Tolerated and Effective: Analysis for the APeX-S Study; Poster #398; Sunday, February 26, 9:45-10:45 am CT
    Berotralstat Improved Quality of Life through 96 Weeks Across Multiple Subgroups of Patients with Hereditary Angioedema; Poster #426; Sunday, February 26, 9:45-10:45 am CT
    Real-World Outcomes in Patients with Hereditary Angioedema (HAE) Treated with Berotralstat; Poster #415; Sunday, February 26, 9:45-10:45 am CT

BioCryst Announces Approval of ORLADEYO® (berotralstat) by the Israeli Ministry of Health

Retrieved on: 
Monday, November 28, 2022
Digoxin, Abdominal pain, PARK, Diarrhea, Liver, CYP3A4, Food, Ciclosporin, Ministry, CYP2D6, BioCryst Pharmaceuticals, HAE, Patient, Plasma kallikrein, Rifampicin, Back pain, Kallikrein, Disease, Vomiting, Hereditary angioedema, Gastroesophageal reflux disease, BCRP, Berotralstat, RESEARCH, Plasma, Safety, Pharmaceutical industry, Dietary supplement, Dentistry, Health, QT

With todays announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.

Key Points: 
  • With todays announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.
  • The approval of ORLADEYO is a major advancement for the HAE community in Israel.
  • The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were back pain and gastrointestinal reactions.
  • The gastrointestinal reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved.

BioCryst Presents Real-World Data Showing Rapid and Sustained HAE Attack Rate Reduction After Beginning ORLADEYO® (berotralstat), Regardless of Prior Prophylactic Therapy

Retrieved on: 
Thursday, November 10, 2022
ACAAI, GLOBE, AES, Convention, IV, Danazol, Gastroesophageal reflux disease, Plasma, Kallikrein, Internal medicine, Adult, Back pain, BioCryst Pharmaceuticals, Plasma kallikrein, Abdominal pain, Nasdaq, Hereditary angioedema, Diarrhea, Incidence, Kentucky International Convention Center, BCRP, HAE, Rifampicin, Liver, Patient, Type 2, Safety, Ciclosporin, Lanadelumab, Berotralstat, RESEARCH, Disease, PARK, CYP3A4, Poster, University, SC, CYP2D6, Food, Digoxin, Vomiting, American College, Pharmaceutical industry, Medical device, Dietary supplement, Dentistry, QT

Every HAE patient has a unique experience with their therapy, and these data demonstrate that ORLADEYO can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history.

Key Points: 
  • Every HAE patient has a unique experience with their therapy, and these data demonstrate that ORLADEYO can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history.
  • Regardless of prior prophylaxis, a rapid reduction in median attack rates was observed early (1.67 attacks/month at baseline to a median attack rate of 0.33 attacks/month in days 1-90).
  • Upon initiating ORLADEYO treatment, the reduction in median attack rates from baseline over the 1360 days period was consistent for patients regardless of their prior prophylaxis therapy.
  • Regardless of baseline attack rate, patients reported a reduction in attack rates when treated with ORLADEYO.

BioCryst to Present New ORLADEYO® (berotralstat) Data at Annual Scientific Meeting of American College of Allergy, Asthma & Immunology

Retrieved on: 
Monday, October 24, 2022
Kentucky International Convention Center, ACAAI, Liver, RESEARCH, Kallikrein, CYP3A4, Diarrhea, Patient, Poster, Rifampicin, Abdominal pain, Back pain, PARK, HAE, BioCryst Pharmaceuticals, Nasdaq, Plasma kallikrein, CYP2D6, Ciclosporin, Hereditary angioedema, Vomiting, Berotralstat, BCRP, Adult, Safety, 2021 Essex County Council election, Food, GLOBE, Plasma, American College, Gastroesophageal reflux disease, Digoxin, Pharmaceutical industry, Dentistry, QT

The meeting will take place at the Kentucky International Convention Center in Louisville, Kentucky, from November 10-14, 2022.

Key Points: 
  • The meeting will take place at the Kentucky International Convention Center in Louisville, Kentucky, from November 10-14, 2022.
  • Rapid and Sustained Reductions in Hereditary Angioedema Attack Rates with Long-term Berotralstat: Real-World Outcomes; Session A; Saturday, November 12, 4:30-5:30 p.m.
  • One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
  • Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

BioCryst Announces Approval of ORLADEYO® (berotralstat) in Saudi Arabia

Retrieved on: 
Thursday, August 18, 2022
FDA, Vomiting, Digoxin, Kallikrein, PARK, GLOBE, RESEARCH, Rifampicin, GCC, Licensed practical nurse, BioCryst Pharmaceuticals, European Medicines Agency, Gulf Cooperation Council, BCRP, Diarrhea, Plasma, Abdominal pain, Patient, Ciclosporin, SFDA, Gastroesophageal reflux disease, Food, CYP3A4, Therapy, Plasma kallikrein, Safety, Berotralstat, HAE, Back pain, Food and Drug Administration, Hereditary angioedema, Nasdaq, Time, Adult, CYP2D6, Liver, Pharmaceutical industry, Dietary supplement, Dentistry, QT

There is a significant need for new treatment options for HAE in Saudi Arabia.

Key Points: 
  • There is a significant need for new treatment options for HAE in Saudi Arabia.
  • This marks the second market in the MENA region in which ORLADEYO has been approved for patients living with HAE, building on the approval in the UAE last year.
  • The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were back pain and gastrointestinal reactions.
  • The gastrointestinal reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved.

Zephyr AI Appoints Allen Hodge as Chief Commercial Officer

Retrieved on: 
Tuesday, August 16, 2022
Software, Biotechnology, Pharmaceutical, Health, Artificial Intelligence, Data Management, Health Technology, Technology, Hematology, Precision medicine, Encorafenib, Drug discovery, CEO, Senior, Algorithm, ViroPharma, Growth, Cancer, Leadership, BioCryst Pharmaceuticals, Zephyr, Research, Pfizer, Marketing, Patient, Instagram, Twitter, Sutro Biopharma, Shire (pharmaceutical company), Hodge, Array BioPharma, Red Cell, BRAF, Diabetes, Hereditary angioedema, Solution, LinkedIn, Celgene, Organization, Pharmaceutical industry, Medical device, United, Berotralstat

Zephyr AI, Inc. (Zephyr AI), a high-growth healthcare technology company committed to radically reshaping traditional approaches to drug discovery precision medicine and predictive analytics has announced the appointment of Allen Hodge as Chief Commercial Officer.

Key Points: 
  • Zephyr AI, Inc. (Zephyr AI), a high-growth healthcare technology company committed to radically reshaping traditional approaches to drug discovery precision medicine and predictive analytics has announced the appointment of Allen Hodge as Chief Commercial Officer.
  • At Zephyr AI, Hodge provides senior leadership and strategic vision to support the companys commercial efforts.
  • The Zephyr AI team is poised to transform the way that the healthcare industry approaches drug discovery, development, and predictive analytics, said Hodge, Chief Commercial Officer of Zephyr AI.
  • As we enter into our next phase of evolution and growth as a company, it is incredibly exciting to welcome Allen to the Zephyr AI team, said David L. Morgan II, CEO of Zephyr AI.