Anifrolumab

Market Access Issues Hindering Specialists’ Use of Advanced Systemics in Lupus Nephritis

Retrieved on: 
Thursday, July 27, 2023
Secukinumab, Obinutuzumab, Tacrolimus, PA, Physician, Rheumatology, Research, Anifrolumab, Patient, Nephrology, Lupus nephritis, Ianalumab, CNI, RealTime, Health insurance, Pharmaceutical industry, Belimumab, LN

Physicians often prescribe alternative treatment options to their LN patients because of high out-of-pocket costs or denied prior authorizations (PA).

Key Points: 
  • Physicians often prescribe alternative treatment options to their LN patients because of high out-of-pocket costs or denied prior authorizations (PA).
  • Rheumatologists and nephrologists are both frustrated with the PA process, managed care hassles, and out-of-pocket costs associated with the recently approved LN drugs.
  • It will be critical for pipeline manufacturers to develop access strategies with payers to ameliorate patient access issues in what is likely to become an increasingly crowded market.
  • Spherix has been tracking the lupus nephritis market quarterly since 2019, prior to the approvals of Benlysta and Lupkynis, to help subscribed clients navigate the rapidly evolving LN market landscape and better understand complicated patient management patterns.

New Research on Emerging Cutaneous Lupus Erythematosus (CLE) Market Reveals Vast Potential for Pipeline Agents, According to Spherix Global Insights

Retrieved on: 
Monday, May 8, 2023
Lupus Foundation of America, Skin condition, GSK, Hydroxychloroquine, Rituximab, Lupus, Flare, DLE, Skin, Rash, Arthralgia, Discoid lupus erythematosus, Biogen, Scar, Woman, Rheumatology, Methotrexate, Belimumab, SLE, CLE, AstraZeneca, Psoriasis, Anifrolumab, Dermatology, Patient, Physician, Lupus nephritis, Diagnosis, Merck, FDA, Skin discoloration, Bristol Myers Squibb, Fatigue, Disease, Cosmetics, Dietary supplement, Pharmaceutical industry, Aurinia

EXTON, Pa., May 8, 2023 /PRNewswire/ -- According to the Lupus Foundation of America, approximately two-thirds of people with the autoimmune condition systemic lupus erythematosus (SLE) will develop some type of skin disease, called cutaneous lupus erythematosus (CLE). Skin disease in lupus can cause rashes or lesions, most of which will appear on the sun-exposed areas of the body.

Key Points: 
  • EXTON, Pa., May 8, 2023 /PRNewswire/ -- According to the Lupus Foundation of America , approximately two-thirds of people with the autoimmune condition systemic lupus erythematosus (SLE) will develop some type of skin disease, called cutaneous lupus erythematosus (CLE).
  • Skin disease in lupus can cause rashes or lesions, most of which will appear on the sun-exposed areas of the body.
  • – Rheumatologist
    There are currently no specific FDA-approved therapies for cutaneous lupus erythematosus (CLE) or discoid lupus erythematosus (DLE) – conditions which mostly affect women and people of color.
  • Spherix Global Insight's Market Dynamix™ Cutaneous Lupus Erythematosus service focuses on this evolving market, where a paradigm shift is expected within the next few years.

Rocket Pharmaceuticals Announces Leadership Expansion to Support Company on Evolution Towards Commercial Stage

Retrieved on: 
Tuesday, April 4, 2023
Health, Genetics, Research, Pharmaceutical, Science, Biotechnology, Vaccine, Inflammation, Faculty, Lupus, Royal college, LV, University, Physician, Royal College of Physicians and Surgeons of Canada, MedImmune, Manchester school, SLE, CMO, AAV, AstraZeneca, Disorder, Medication, Anifrolumab, M.D, Patient, Rocket, Hematology, Growth, Rare, Cardiology, Rest, News, Pharmaceutical medicine, Disease, Pharmaceutical industry, Medical device

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced expansion of its leadership team to support its growing and industry-leading pipeline of AAV and LV gene therapy assets and evolution towards commercial stage.

Key Points: 
  • Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced expansion of its leadership team to support its growing and industry-leading pipeline of AAV and LV gene therapy assets and evolution towards commercial stage.
  • “Today’s news represents another exciting and important step forward in our leadership team as we make meaningful strides in our evolution towards commercial stage, adding deep late-stage development expertise and commercial experience to our team along with intensified focus on applying our technologies and successes to date across our pipeline,” said Gaurav Shah, M.D, Chief Executive Officer, Rocket Pharma.
  • “Jonathan’s exceptional scientific and clinical thought leadership will help unlock the full potential of gene therapy platforms for our pipeline and help advance the industry at large.
  • As Chief Gene Therapy Officer, Dr. Schwartz will oversee research, deepen relationships with external collaborators, and offer a pointed focus on clinical strategy and pipeline expansion.

Introduction of AstraZeneca's Saphnelo (anifrolumab) has Expanded the Use of Biologic Agents in the Treatment of Systemic Lupus Erythematosus (SLE), Resulting in Gains for GSK's Benlysta (belimumab) as Well, According to Spherix Global Insights

Retrieved on: 
Wednesday, February 22, 2023
Pfizer, Safety, Skin, The Hassles, Disease, Insurance, UCB, Research, Perception, Rheumatology, Obinutuzumab, Patient, SLE, Benchmarking, Lupus nephritis, Nephritis, Steroid, Arthritis, Student, Bristol Myers Squibb, Physician, Pharmaceutical industry, Dietary supplement, Anifrolumab, Belimumab, Biogen

EXTON, Pa., Feb. 22, 2023 /PRNewswire/ -- Rheumatologists have long struggled to effectively treat patients with systemic lupus erythematosus (SLE) given the wide heterogeneity of the disease and few effective treatment options.

Key Points: 
  • EXTON, Pa., Feb. 22, 2023 /PRNewswire/ -- Rheumatologists have long struggled to effectively treat patients with systemic lupus erythematosus (SLE) given the wide heterogeneity of the disease and few effective treatment options.
  • While share for Saphnelo among patients with moderate-to-severe SLE remains modest, the introduction of a new agent seems to have propelled the overall use of biologics.
  • Between October 2021 and January 2023, biologic share – consisting of Benlysta, Saphnelo, and off-label rituximab – moved from 16% to 26% according to self-reported use by rheumatologists.
  • "In general, I do see better steroid-sparing with the use of Saphnelo than with Benlysta and a much faster reduction of steroids.

Major Shifts in Management of Patients with Lupus Nephritis Spurred by Availability of Aurinia Pharmaceutical's Lupkynis and GSK's Benlysta, According to Spherix Global Insights

Retrieved on: 
Friday, January 20, 2023
Safety, Rituximab, Lupus nephritis, Hypertension, AstraZeneca, Skin, Novartis, Rheumatology, Secukinumab, Nephrology, FDA, Thumbay Hospital, Physician, Anemia, SGLT2, GSK plc, NASA RealWorld-InWorld Engineering Design Challenge, Roche, Proteinuria, EGFR, Patient, Clinical trial, Disease, Steroid, Research, Medical imaging, Pharmaceutical industry, Nursing, Belimumab, Aurinia, Anifrolumab, LN, Voclosporin

EXTON, Pa., Jan. 20, 2023 /PRNewswire/ -- With the approvals of GlaxoSmithKline's Benlysta (belimumab) in lupus nephritis (LN) at the end of 2020 and Aurinia's Lupkynis (voclosporin) at the beginning of 2021, practitioners now have valuable new treatment options to battle this complex and serious condition.

Key Points: 
  • Spherix Global Insights has been a leader in tracking the lupus nephritis market for several years, covering physician perspectives, treatment patterns, and pipeline assessments.
  • Compared to the prior year (n=954 patients), use of Aurinia's novel calcineurin inhibitor expanded significantly, regardless of which specialty was managing the treatment regimen.
  • Use of Benlysta was relatively flat with rheumatology-managed patients being far more likely to be treated with the agent than nephrology-managed patients.
  • LN patients under nephrology management were three times as likely to be on an SGLT2 inhibitor compared to those under management of a rheumatologist.

European Lupus Market Coverage Highlights Pipeline Perceptions and Country Differences in Patient Management, Spherix Reports

Retrieved on: 
Wednesday, October 26, 2022
Quality of life, SLE, Physician, National Institute, Time, AstraZeneca, Disease, Review, Ophthalmology, Dermatology, UCB, Lupus, Pfizer, Patient, Hydroxychloroquine, Rheumatology, Research, Gastroenterology, PGA, Lupus nephritis, Obinutuzumab, Neurology, GlaxoSmithKline, National Institute for Health and Care Excellence, Incidence, Health, NICE, Clinical trial, Flare, Bristol Myers Squibb, Belimumab, Anifrolumab, QOL, Pregnancy, Nephrology, JAK, Lists of people executed in the United States, Pharmaceutical industry, Biogen, LN, Aurinia, EU

EXTON, Pa., Oct. 26, 2022 /PRNewswire/ -- Rheumatologists have long struggled to effectively treat patients with systemic lupus erythematosus (SLE) given the wide heterogeneity of the disease and few effective treatment options. However, after nearly a decade of stagnant innovation for the treatment of SLE and lupus nephritis (LN), physicians now have three recently approved agents in their treatment armamentarium: GlaxoSmithKline's Benlysta (belimumab) in SLE and now LN, AstraZeneca's Saphnelo (anifrolumab) in SLE, and Aurinia's Lupkynis (voclosporin) in LN.

Key Points: 
  • Spherix Global Insights has been a leader in tracking the SLE and LN markets for several years, covering physician perspectives, treatment patterns, and pipeline assessments.
  • This coverage includes in-depth interviews with key opinion leaders (KOLs) and "in-the-trenches" physicians, along with large-scale attitudinal surveys and chart audits of more than 1000 patients.
  • Market-trending and future-looking reports, coupled with patient chart audits and launch trackers, enable subscribed clients to intelligently strategize as they strive towards optimal patient care and maximal market share.
  • RealWorld Dynamixis an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits.

Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 27, 2022
Pharmaceutical, Health, Clinical Trials, Hormone, B-cell activating factor, Lupus, Neuropsychiatric systemic lupus erythematosus, GlaxoSmithKline, PDUFA, AstraZeneca, Clinical trial, Probability, Acquisition, Anifrolumab, CHMP, Patent, SLE, NDA, Pharmaceutical industry, Phase II

This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Points: 
  • This Market Spotlight report covers the Systemic Lupus Erythematosus (SLE) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, epidemiology information, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
  • The approved drugs in the systemic lupus erythematosus (SLE) space target B-cell activating factor, glucocorticoid receptor, corticotropin releasing factor, and corticotropin releasing hormone.
  • The majority of industry-sponsored drugs in active clinical development for SLE are in Phase II, with only one drug in the NDA/BLA phase.
  • GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for SLE, followed by AstraZeneca.

Lupus Researchers Receive Prestigious Awards for Distinguished Contributions to the Field

Retrieved on: 
Wednesday, December 8, 2021
Estrogen, Medical research, Belimumab, LFA, Feinstein Institute for Medical Research, Research, Health, Associate, University of Virginia Health System, Tissue, Lupus, Therapy, Medical school, Health system, Walter Hamilton (Master of Magdalene College), Anifrolumab, Woman, Autoimmune disease, Lupus Foundation of America, Quality of life, Northwell Health, Patient, Industry, SERM, Weatherall Institute of Molecular Medicine, Marilyn, American College, Medical University of South Carolina, Science, Lists of diseases, MD, Education, Division, Perseverance, Molecular medicine, Program, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Evelyn, American College of Rheumatology, Doctor of Philosophy, SLE, Institute, MUSC, Student, Pharmaceutical industry, Medicine, Medical device

He directs The Program in Novel Therapeutics, the Health System's clinical research program in musculoskeletal disease.

Key Points: 
  • He directs The Program in Novel Therapeutics, the Health System's clinical research program in musculoskeletal disease.
  • Recognized in the New York metropolitan area as a senior rheumatologist, Dr. Furie has served as an advisor for the LFA.
  • "I am pleasantly surprised by this recognition and truly honored to receive the Evelyn V. Hess Award from the Lupus Foundation of America," said Dr. Furie.
  • Through a comprehensive program of research, education, and advocacy, we lead the fight to improve the quality of life for all people affected by lupus.

Novel Agents in Systemic Lupus Erythematosus (AstraZeneca's anifrolumab) and Lupus Nephritis (Aurinia Pharmaceutical's voclosporin and GSK's belimumab) Introduce Paradigm Shifts, According to Spherix Global Insights

Retrieved on: 
Thursday, November 4, 2021
Lupus, Benchmarking, Safety, Surveillance, Thumbay Hospital, IFN, CNI, Clinical trial, MOA, Lupus nephritis, BMS, Pitting corrosion, Nephrology, Anifrolumab, Rheumatology, Woman, Acquisition, JAK, Eli Lilly and Company, Nephritis, Moa, GSK, AstraZeneca, FDA, Patient, Pharmaceutical industry, Fine chemical, Generic drug

For market access issues, there is no consensus regarding the efficacy profiles of the two drugs.

Key Points: 
  • For market access issues, there is no consensus regarding the efficacy profiles of the two drugs.
  • With lupus being two to three times more prevalent in women of color,1 this could be a key advantage for the newly launched brand.
  • The third novel agent to enter the SLE/LN market is Aurinia Pharmaceuticals' Lupkynis (voclosporin), a novel calcineurin inhibitor (CNI) which was approved in January of this year.
  • Whether these three agents can establish a stronghold prior to the wave of incoming pipeline agents for SLE and LN remains in question.

SAPHNELO (anifrolumab) Approved in the US for Moderate to Severe Systemic Lupus Erythematosus

Retrieved on: 
Monday, August 2, 2021
FDA, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Medical specialties, Autoimmune diseases, Clinical medicine, Medicine, Cutaneous lupus erythematosus, Connective tissue diseases, Lupus, William Osler, Syndromes, Anifrolumab, Sjögren syndrome, Rheumatology

AstraZenecas SAPHNELO (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

Key Points: 
  • AstraZenecas SAPHNELO (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
  • SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
  • Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.
  • The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases.