Immunosuppressants

Genentech’s Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children

Retrieved on: 
Friday, June 25, 2021
Infectious diseases, FDA, Hospitals, Public policy, Government, Biotechnology, White House, Federal Government, Health, Pharmaceutical, General Health, Health sciences, Health, Immunosuppressants, Orphan drugs, Clinical research, Pharmaceutical industry, Tocilizumab, Drug discovery, COVID-19, Genentech, Clinical trial, Food and Drug Administration, the Emergency Use Authorization (EUA) for Actemra, the Actemra COVID-19 Clinical Trial Program, Actemra, Genentech, THE EMERGENCY USE AUTHORIZATION (EUA) FOR ACTEMRA, THE ACTEMRA COVID-19 CLINICAL TRIAL PROGRAM, ACTEMRA, GENENTECH

We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.

Key Points: 
  • We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.
  • The RECOVERY Actemra study was led by researchers in the United Kingdom and included more than 4,000 hospitalized COVID-19 patients.
  • Actemra has not been approved by the U.S. FDA in this setting, but the FDA has made Actemra available under an emergency access mechanism called an EUA as a treatment for certain patients with COVID-19.
  • Genentechs clinical trial program evaluated the safety and efficacy of Actemra in hospitalized patients with COVID-19.

Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19

Retrieved on: 
Friday, June 25, 2021
Medical specialties, Health care, Clinical medicine, Immunosuppressants, Orphan drugs, Tocilizumab, Rheumatology, Arthritis

The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.

Key Points: 
  • The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.
  • Actemra is a prescription medication given by intravenous infusion that is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.
  • Under today's EUA, the FDA is authorizing the emergency use of Actemra for the treatment of certain hospitalized patients with COVID-19.
  • Common side effects of Actemra observed in the COVID-19 trials include constipation, anxiety, diarrhea, insomnia, hypertension and nausea.

DGAP-News: Abivax reports excellent phase 2a clinical safety and efficacy results with 50mg ABX464 in rheumatoid arthritis

Retrieved on: 
Wednesday, June 23, 2021
Medical specialties, Clinical medicine, Medicine, Autoimmune diseases, Rheumatology, Immunosuppressants, Monoclonal antibodies, Abivax, Ulcerative colitis, Arthritis, Rheumatoid arthritis, Filgotinib, ABX464[8][9], Abivax (www.abivax.com), ABX464[8][9], ABIVAX (WWW.ABIVAX.COM)

The ACR20 is the key primary efficacy endpoint required by the FDA for licensure of new drugs in rheumatoid arthritis.

Key Points: 
  • The ACR20 is the key primary efficacy endpoint required by the FDA for licensure of new drugs in rheumatoid arthritis.
  • Based on these results, Abivax is preparing to start a clinical phase 2b program in RA in early 2022.
  • ABX464 was already shown to be efficacious and safe in phase 2a and phase 2b clinical studies for the treatment of ulcerative colitis (UC).
  • Therefore, the 100mg dose will not be considered for future clinical development of ABX464 in rheumatoid arthritis.

New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis: COBRA study presented at the 7th Congress of the European Academy of Neurology (EAN)

Retrieved on: 
Tuesday, June 22, 2021
Biotechnology, Other Health, Health, Pharmaceutical, Clinical trials, Medical specialties, Medicine, Glatiramer acetate, Immunology, Multiple sclerosis, Breastfeeding, Immunosuppressants, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Multiple sclerosis drug pipeline, the Study, COPAXONE®, Teva, THE STUDY, COPAXONE®, TEVA

The COBRA study used data from the National German Multiple Sclerosis and Pregnancy Registry from 2011 to 2020.

Key Points: 
  • The COBRA study used data from the National German Multiple Sclerosis and Pregnancy Registry from 2011 to 2020.
  • Patients were eligible for the study if they were diagnosed with relapsing MS (RMS), gave a live birth, were breastfeeding under GA treatment (Copaxone 20 or 40 mg/mL) or breastfeeding under no DMT treatment.
  • Real-world safety of Copaxone in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis (RMS) pAtients (COBRA study) was retrospective data analysis using the national German Multiple Sclerosis and Pregnancy Registry.
  • Al, Safety analysis of offspring breastfed by mothers on glatiramer acetate therapy for relapsing multiple sclerosis; presented at EAN 2021.

TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis at 7th Congress of the European Academy of Neurology

Retrieved on: 
Friday, June 18, 2021
Chemistry, Physical sciences, Materials, Anilides, Immunosuppressants, Sanofi, Enols, Nitriles, Teriflunomide, Gadolinium

In ULTIMATE II, treatment with ublituximab resulted in an ARR of 0.091 compared to 0.178 for teriflunomide, representing a relative reduction of approximately 50% (p=0.0022).

Key Points: 
  • In ULTIMATE II, treatment with ublituximab resulted in an ARR of 0.091 compared to 0.178 for teriflunomide, representing a relative reduction of approximately 50% (p=0.0022).
  • Total number ofT1 Gadolinium (Gd)enhancing lesionswere reduced as a result of ublituximab treatment by 97% and 96% relative to treatment with teriflunomide in ULTIMATE I & II, respectively(p
  • New or enlargingT2 lesionswere reduced as a result of ublituximab treatment by 92% and 90% relative to treatment with teriflunomide in ULTIMATE I & II, respectively(p
  • The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries.

European Commission approves Aubagio® (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis

Retrieved on: 
Friday, June 18, 2021
Multiple sclerosis, Medicine, Medical specialties, Clinical medicine, Nitriles, Immunosuppressants, Autoimmune diseases, Teriflunomide, Multiple sclerosis drug pipeline, Multiple sclerosis research

PARIS June 18, 2021 - The European Commission (EC) has approved Aubagio (teriflunomide) for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS).

Key Points: 
  • PARIS June 18, 2021 - The European Commission (EC) has approved Aubagio (teriflunomide) for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS).
  • The approval confirms Aubagio as the first oral multiple sclerosis (MS) therapy for first-line treatment of children and adolescents with MS in the European Union.
  • The European approval of Aubagio in pediatrics means young people with MS have a new treatment option, and importantly - one that can offer meaningful improvement in managing this serious disease.
  • Multiple sclerosis is a chronic neurodegenerative disease in which a person's immune system causes damage to the brain and spinal cord.

Data Published in New England Journal of Medicine Shows Pfizer’s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia

Retrieved on: 
Wednesday, June 16, 2021
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Infectious diseases, Clinical trials, Clinical research, Design of experiments, Health sciences, Articles, Immunosuppressants, Health, Tofacitinib, COVID-19, Placebo-controlled study, Randomized controlled trial

Serious adverse events occurred in 20 patients (14.1%) in the tofacitinib group and 17 (12.0%) in the placebo group.

Key Points: 
  • Serious adverse events occurred in 20 patients (14.1%) in the tofacitinib group and 17 (12.0%) in the placebo group.
  • We are encouraged by the initial findings of our randomized trial of tofacitinib in patients hospitalized with COVID-19 pneumonia.
  • The study builds on the hypothesis that JAK inhibition could mitigate systemic and alveolar inflammation in patients with COVID-19-related pneumonia.
  • The multi-center, randomized, double-blind, placebo-controlled trial included adult patients hospitalized with COVID-19 pneumonia receiving standard of care.

Alvotech Reaches Primary Completion Date in Its Switching Study for AVT02, a Proposed Interchangeable Biosimilar to AbbVie’s Humira®

Retrieved on: 
Tuesday, June 15, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Drugs, Life sciences, Biotechnology, Articles, Biosimilar, Immunosuppressants, Monoclonal antibodies, TNF inhibitors, Adalimumab

Alvotech, today, announced reaching the primary completion date in the switching study for AVT02, the companys proposed interchangeable biosimilar to Humira.

Key Points: 
  • Alvotech, today, announced reaching the primary completion date in the switching study for AVT02, the companys proposed interchangeable biosimilar to Humira.
  • Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira and is executing a switching study to support approval as an interchangeable product.
  • The completion of the comparative treatment phase of the switching study is a key milestone in our program for our AVT02 interchangeable biosimilar candidate.
  • In order to be considered interchangeable, a biosimilar must meet additional requirements, including the execution of an interchangeable switching study, utilizing the innovator and biosimilar product in patients.

Adalimumab Biosimilar Market Insight Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 10, 2021
Health, Pharmaceutical, Drugs, Life sciences, Immunosuppressants, TNF inhibitors, Monoclonal antibodies, Biotechnology, Adalimumab, Biosimilar

The "Adalimumab - Biosimilar Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Adalimumab - Biosimilar Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "Adalimumab- Biosimilar Insight, 2021," report provides comprehensive insights about 35+ companies and 35+ marketed and pipeline drugs in Adalimumab Biosimilars landscape.
  • Abrilada is an FDA-approved biosimilar version of adalimumab.
  • Bio-Thera Solutions has received approval from the country's National Medical Products Administration (NMPA) for Qletli, a biosimilar to AbbVie's Humira (adalimumab).

Starton Therapeutics Advances STAR-LLD Transdermal Lenalidomide Following Successful Skin Permeation Studies

Retrieved on: 
Wednesday, June 9, 2021
Medicine, Clinical medicine, Drugs, Immunosuppressants, Aromatic amines, Routes of administration, Lenalidomide, Transdermal

With this milestone, Starton has advanced multiple formulation candidates in its transdermal lenalidomide (STAR-LLD) program into nonclinical studies.

Key Points: 
  • With this milestone, Starton has advanced multiple formulation candidates in its transdermal lenalidomide (STAR-LLD) program into nonclinical studies.
  • The invention includes a unique Method of Use with a pretreatment to modulate the outermost layer of the skin reversibly and facilitate drug uptake.
  • Using a 505(b)(2) approval path, Starton is not anticipating to have to repeat nonclinical safety studies.
  • Once target blood levels and skin tolerability are demonstrated, Starton will select a lead candidate to advance into human clinical trials.