Mycophenolic acid

Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

$1,361.9 Prescription Drugs Markets - Global Forecasts from 2022 to 2027 - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 12, 2023

The "Global Prescription Drugs Market - Forecasts from 2022 to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Prescription Drugs Market - Forecasts from 2022 to 2027" report has been added to ResearchAndMarkets.com's offering.
  • The increasing number of chronic diseases worldwide is further continuing to increase the sales of prescription drugs in the forecast period.
  • The market for prescription drugs will further proliferate with the research and development investments among companies for the manufacturing of innovative drugs.
  • The developed regions of the world, particularly, North America, are projected to hold a significant market share in the global prescription drug market.

COVID-19 Vaccine Clinical Trial in People With Autoimmune Disease Starts at Feinstein Institutes

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Thursday, September 2, 2021

As part of a new National Institutes of Health (NIH) coronavirus disease 2019 (COVID-19) vaccine clinical trial, The Feinstein Institutes for Medical Research the science arm of Northwell Health delivered its first set of extra shots to eligible New York patients with an autoimmune disease.

Key Points: 
  • As part of a new National Institutes of Health (NIH) coronavirus disease 2019 (COVID-19) vaccine clinical trial, The Feinstein Institutes for Medical Research the science arm of Northwell Health delivered its first set of extra shots to eligible New York patients with an autoimmune disease.
  • View the full release here: https://www.businesswire.com/news/home/20210902005824/en/
    Robert Cass became the first clinical trial participant in New York living with an autoimmune disease to receive his extra COVID-19 vaccine.
  • (Credit: Feinstein Institutes)
    An estimated 8 percent of Americans have an autoimmune disease and COVID-19 has disproportionality affected this vulnerable population.
  • It is called the COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders and will study the antibody response to an extra shot of an authorized or approved COVID-19 vaccine in people with an autoimmune disease whose body did not respond to an original vaccine regimen.

Lannett Commences Marketing Mycophenolate Mofetil For Oral Suspension

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Monday, August 30, 2021

PHILADELPHIA, Aug. 30, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has commenced marketing Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, an internally developed product.

Key Points: 
  • PHILADELPHIA, Aug. 30, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has commenced marketing Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, an internally developed product.
  • "Our Abbreviated New Drug Application (ANDA) for Mycophenolate Mofetil for Oral Suspension received a first-cycle approval from the FDA, which underscores the quality of our filing, as well as our product development team," said Tim Crew, chief executive officer of Lannett.
  • Currently, only two other competitors market generic Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, in the U.S."
    Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL, bioequivalent and therapeutically equivalent to the reference listed drug (RLD) CellCept Oral Suspension 200 mg/mL of Roche Palo Alto LLC, is indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immune-suppressants.
  • Mycophenolate Mofetil for Oral Suspension is subject to a Risk Evaluation and Mitigation Strategies (REMS) program.

RECIPE Randomized Controlled Trial Data Published in Arthritis & Rheumatology Show Higher Response Rates Using KRYSTEXXA® (pegloticase injection) with the Immunomodulator Mycophenolate Mofetil

Retrieved on: 
Wednesday, April 7, 2021

Horizon Therapeutics plc (Nasdaq: HZNP) announced the publication of data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [ doi.org/10.1002/art.41731 ].

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) announced the publication of data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [ doi.org/10.1002/art.41731 ].
  • The safety and efficacy of KRYSTEXXA co-prescribed with mycophenolate mofetil has not been established by any health authorities.
  • During the trial, patients continued to receive either mycophenolate mofetil (1g) twice daily or placebo with KRYSTEXXA for 12 weeks.
  • Reducing Immunogenicity of Pegloticase (RECIPE) with Concomitant Use of Mycophenolate Mofetil in Patients with Refractory Gout a Phase II Double Blind Placebo Controlled Randomized Trial.

Aurinia Presents Additional AURORA Pivotal Trial Safety Data at the ERA-EDTA Virtual Congress 2020

Retrieved on: 
Tuesday, June 9, 2020

All patients in the AURORA study were treated with mycophenolate (MMF) and a background of corticosteroids.

Key Points: 
  • All patients in the AURORA study were treated with mycophenolate (MMF) and a background of corticosteroids.
  • Our deep analysis of the comprehensive voclosporin clinical program continues to illustrate its potential as a treatment for lupus nephritis.
  • This data has been submitted to the FDA as part of voclosporins recently completed New Drug Application.
  • Overall mortality in the trial was low, with six deaths observed; one in the voclosporin arm and five in the control group.

Aurinia Presents AURORA Pivotal Trial Subgroup Analysis at the EULAR 2020 E-Congress

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Friday, June 5, 2020

Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that new subgroup analyses from the completed AURORA pivotal trial of voclosporin were presented.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that new subgroup analyses from the completed AURORA pivotal trial of voclosporin were presented.
  • The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race.
  • Furthermore, all other pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior mycophenolate mofetil use) favored voclosporin.
  • Overall mortality in the trial was low, with six deaths observed; one in the voclosporin arm and five in the control group.

Progressive-Fibrosing Interstitial Lung Disease (PF-ILD): Market Insights, Epidemiology and Forecast to 2028 - ResearchAndMarkets.com

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Monday, April 27, 2020

The "Progressive-Fibrosing Interstitial Lung Disease (PF-ILD) - Market Insights, Epidemiology, and Market Forecast - 2028" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Progressive-Fibrosing Interstitial Lung Disease (PF-ILD) - Market Insights, Epidemiology, and Market Forecast - 2028" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • According to this research, the total prevalent population of Interstitial Lung Disease in seven major markets was 736,184 in 2017.
  • The current market size of PF-ILD is mainly attributed by corticosteroids, mycophenolate mofetil, azathioprine, cyclosporine, tacrolimus, and cyclophosphamide.
  • The market size is expected to increase during the forecast period (2019-2028), due to potential therapies nintedanib (Ofev) and pirfenidone (Esbriet).

Study Reveals Possible Drug Treatment for Lupus Kidney Disease

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Wednesday, March 25, 2020

NEW YORK, March 25, 2020 /PRNewswire/ -- Today, the National Kidney Foundation (NKF) showcased a global study designed to understand the experimental immunosuppressant drug Voclosporin as a treatment for patients with lupus kidney disease.

Key Points: 
  • NEW YORK, March 25, 2020 /PRNewswire/ -- Today, the National Kidney Foundation (NKF) showcased a global study designed to understand the experimental immunosuppressant drug Voclosporin as a treatment for patients with lupus kidney disease.
  • Aurora is a global study designed tohelp us understand if adding voclosporin to mycophenolate mofetil (MMF) and steroids, common treatments for lupus kidney disease , will improve outcomes in patients with active lupus kidney disease.
  • "We know that achieving remission status in lupus kidney disease correlates with good long-term kidney survival and so the results of this study are very encouraging," added Dr. Gibson.
  • Based on the results of this study, Aurinia plans to file an application with the FDA for approval, which if approved, will open access to this medication to patients with lupus kidney disease.

Aurinia Announces AURORA Phase 3 Clinical Data for Voclosporin in Lupus Nephritis to be Presented at National Kidney Foundation 2020 Spring Clinical Meetings

Retrieved on: 
Wednesday, March 18, 2020

The AURORA pivotal trial evaluated voclosporin in combination with mycophenolate (MMF) and low-dose corticosteroids for the treatment of lupus nephritis (LN).

Key Points: 
  • The AURORA pivotal trial evaluated voclosporin in combination with mycophenolate (MMF) and low-dose corticosteroids for the treatment of lupus nephritis (LN).
  • Aurinia previously announced positive efficacy and safety results from the AURORA Phase 3 pivotal trial in December 2019.
  • Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (CNI) with clinical data in over 2,600 patients across indications.
  • Lupus nephritis (LN) is an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE.