Rilonacept

Kiniksa Announces Issuance of U.S. Patent for Treatment of Recurrent Pericarditis

Retrieved on: 
Tuesday, June 8, 2021
Medical specialties, Clinical medicine, Medicine, Pericarditis, Rilonacept, Acute pericarditis

Patients who have additional pericarditis episodes following a symptom-free period of 4-6 weeks are identified as having recurrent pericarditis.

Key Points: 
  • Patients who have additional pericarditis episodes following a symptom-free period of 4-6 weeks are identified as having recurrent pericarditis.
  • Recurrent pericarditis symptoms have an impact on quality of life, limit physical activities, and lead to frequent emergency department visits and hospitalizations.
  • Data show that approximately 40,000 patients in theU.S.seek and receive treatment for recurrent pericarditis each year.
  • The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020.

Kiniksa Announces Commercial Availability of ARCALYST ® (rilonacept) for Recurrent Pericarditis

Retrieved on: 
Thursday, April 1, 2021
Medical specialties, Health care, Orphan drugs, Clinical medicine, Immunosuppressants, Rilonacept, Pericarditis, Breakthrough therapy

We are excited to announce that ARCALYST is now available as the first and only approved therapy for patients with recurrent pericarditis, said Ross Moat, ARCALYST General Manager.

Key Points: 
  • We are excited to announce that ARCALYST is now available as the first and only approved therapy for patients with recurrent pericarditis, said Ross Moat, ARCALYST General Manager.
  • Kiniksa is committed to patient access and has established Kiniksa One Connect, our patient support program, which provides comprehensive access and support services for any patient prescribed ARCALYST.
  • Patients who have additional pericarditis episodes following a symptom-free period of 4-6 weeks are identified as having recurrent pericarditis.
  • The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020.

Kiniksa Announces FDA Approval of ARCALYST ® (rilonacept) for Recurrent Pericarditis

Retrieved on: 
Thursday, March 18, 2021
Medical specialties, Health sciences, Health care, Immunosuppressants, Rilonacept, Regeneron Pharmaceuticals, Pericarditis, Breakthrough therapy, Orphan drugs

The FDA approval of ARCALYST in recurrent pericarditis follows positive data from RHAPSODY, a pivotal Phase 3 trial of ARCALYST in recurrent pericarditis.

Key Points: 
  • The FDA approval of ARCALYST in recurrent pericarditis follows positive data from RHAPSODY, a pivotal Phase 3 trial of ARCALYST in recurrent pericarditis.
  • Kiniksa will host a conference call and webcast at5:30 p.m. Eastern TimeonThursday, March 18, 2021to discuss the FDA approval of ARCALYST for recurrent pericarditis.
  • The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020.
  • Upon approval of ARCALYST in recurrent pericarditis, Kiniksa is obligated to make a $20 million milestone payment to Regeneron.

Kiniksa Highlights Corporate Priorities and Expected 2021 Milestones

Retrieved on: 
Monday, January 11, 2021
Medical specialties, Clinical medicine, Medicine, Food and Drug Administration, Pharmaceuticals policy, Prescription Drug User Fee Act, Rilonacept, Giant cell arteritis

- PDUFA goal date of March 21, 2021 for rilonacept in recurrent pericarditis -

Key Points: 
  • - PDUFA goal date of March 21, 2021 for rilonacept in recurrent pericarditis -
    HAMILTON, Bermuda, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today highlighted its corporate priorities and expected 2021 milestones.
  • Kiniksa plans to provide next steps for the development of mavrilimumab, including for giant cell arteritis (GCA), in the first half of 2021.
  • The company expects to provide data from the Phase 2 portion of the trial in the first half of 2021.
  • Kiniksa expects final data and safety follow-up from all cohorts in the first half of 2021.

Kiniksa Announces U.S. FDA Acceptance of sBLA and Priority Review for Rilonacept in Recurrent Pericarditis

Retrieved on: 
Monday, November 23, 2020
Medical specialties, Immunology, Clinical medicine, Immunosuppressants, Rilonacept, Pericarditis, Regeneron Pharmaceuticals, Breakthrough therapy, Autoinflammatory syndromes

The FDA granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for the treatment of pericarditis in 2020.

Key Points: 
  • The FDA granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for the treatment of pericarditis in 2020.
  • The regulatory submission was based on positive data from RHAPSODY, a pivotal Phase 3 trial of rilonacept in recurrent pericarditis.
  • Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both IL-1 and IL-1, including recurrent pericarditis.
  • Kiniksa continues to prepare for the potential commercial launch of rilonacept in recurrent pericarditis.

Kiniksa Announces New England Journal of Medicine Publication of Rilonacept Phase 3 Data in Recurrent Pericarditis and Late-Breaking Science Presentation at American Heart Association Scientific Sessions 2020

Retrieved on: 
Tuesday, November 17, 2020
Medical specialties, Clinical medicine, Medicine, Immunosuppressants, Rilonacept, Pericarditis, Carditis

Additionally, the RHAPSODY data were presented at the late-breaking science session during the American Heart Association (AHA) Scientific Sessions 2020.

Key Points: 
  • Additionally, the RHAPSODY data were presented at the late-breaking science session during the American Heart Association (AHA) Scientific Sessions 2020.
  • The manuscript entitled Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis, is available on The New England Journal of Medicine website with open access for seven days.
  • Data were reported which showed that patients treated with rilonacept experienced a 96% reduction in risk of recurrent pericarditis events.
  • These data suggest that targeted immunomodulation with rilonacept may signal a paradigm shift in the management of patients with recurrent pericarditis.

Kiniksa Announces Rilonacept Analyst Day Now Tuesday, September 29th

Retrieved on: 
Thursday, September 24, 2020
Medical specialties, Clinical medicine, RTT, Immunosuppressants, Rilonacept, Health, Pericarditis, Breakthrough therapy

The event will feature presentations from the Kiniksa management team on the market opportunity for rilonacept in recurrent pericarditis as well as the companys continued commercial preparations and launch strategy.

Key Points: 
  • The event will feature presentations from the Kiniksa management team on the market opportunity for rilonacept in recurrent pericarditis as well as the companys continued commercial preparations and launch strategy.
  • Kiniksa will host a webcast and conference call at 8:00 a.m. Eastern Daylight Time on Tuesday, September 29th, 2020.
  • The presentation will be accessible through this link as well as through the Investors & Media section of the company's website .
  • The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020.

Kiniksa Announces Upcoming Rilonacept Analyst Day

Retrieved on: 
Monday, September 21, 2020
Medical specialties, Articles, Immunology, Immunosuppressants, Rilonacept, Regeneron Pharmaceuticals, Breakthrough therapy, Pericarditis, Autoinflammatory syndromes

Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both interleukin-1 alpha (IL-1) and interleukin-1 beta (IL-1), including recurrent pericarditis.

Key Points: 
  • Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both interleukin-1 alpha (IL-1) and interleukin-1 beta (IL-1), including recurrent pericarditis.
  • The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020.
  • Thereafter, Kiniksa and Regeneron will evenly split profits on sales of rilonacept after deducting certain commercialization expenses subject to specified limits.
  • The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020.

Kiniksa Presents Data on the Burden of Disease in Patients with Recurrent Pericarditis at the European Society of Cardiology Congress 2020

Retrieved on: 
Monday, August 31, 2020
Medical specialties, Clinical medicine, RTT, Medicine, Pericarditis, Rilonacept, Breakthrough therapy

Quantifying the impact of recurrent pericarditis on important health-related quality of life measures, including physical and emotional well-being, has enabled a more complete appreciation of the overall burden of recurrent pericarditis.

Key Points: 
  • Quantifying the impact of recurrent pericarditis on important health-related quality of life measures, including physical and emotional well-being, has enabled a more complete appreciation of the overall burden of recurrent pericarditis.
  • Kiniksa reported positive data from RHAPSODY, a global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis.
  • RHAPSODY showed that rilonacept improved clinically meaningful outcomes associated with the unmet medical need in recurrent pericarditis for patients in the study.
  • The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020.

Kiniksa Announces U.S. Orphan Drug Designation for Rilonacept for the Treatment of Pericarditis

Retrieved on: 
Thursday, July 16, 2020
Health, Articles, Life sciences, Pharmaceuticals policy, Immunosuppressants, Rilonacept, Orphan drug, Breakthrough therapy, Regeneron Pharmaceuticals, Food and Drug Administration, Pericarditis

Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both IL-1 and IL-1, including recurrent pericarditis.

Key Points: 
  • Kiniksa licensed rilonacept from Regeneron in 2017 for evaluation in diseases believed to be mediated by both IL-1 and IL-1, including recurrent pericarditis.
  • The FDA grants Orphan Drug designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics.
  • Additionally, orphan drug designation waives the requirement to conduct pediatric studies for the product in the disease it is designated.
  • The FDA granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020.