aurinia pharmaceuticals fda

At a time when our nation faces extreme challenges such as addressing and overcoming social inequities and health disparities, this is welcome and promising news, especially since both lupus nephritis and COVID-19 disproportionately impact communities of color.”. Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Treatment for: Lupus Nephritis Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of … FDA Approved: Yes (First approved January 22, 2021) Brand name: Lupkynis Generic name: voclosporin Dosage form: Capsules Company: Aurinia Pharmaceuticals Inc. To learn more about Aurinia Alliance or LUPKYNIS, visit www.LUPKYNIS.com. Today, Aurinia Pharmaceuticals announced they received authorization from the FDA to market Lupkynis™ (voclosporin), a first-ever oral therapy for lupus nephritis that blocks a protein in the immune system called calcineurin. These forward-looking statements or information include but are not limited to statements, information or public presentations with respect to: voclosporin being a potential treatment for LN; a PDUFA target action date of January 22, 2021; that we will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021; voclosporin being potentially a best-in-class CNI; Aurinia’s anticipation that upon regulatory approval, patent protection for voclosporin composition of matter will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; a US patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and the AURORA studies into the product label. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation. 76.4% of retail CFD accounts lose money, https://www.businesswire.com/news/home/20210122005501/en/, Registration on or use of this site constitutes acceptance of our, U.S. markets open in 14 minutes 23 seconds, US stock futures mixed after tech stages biggest rally since November - with all eyes on inflation data », Wharton professor Jeremy Siegel says value stocks will outperform tech this year in 'the hottest economy we're going to see in a long time' », Aurinia Pharmaceuticals to Present at Three Upcoming March Investor Conferences, Aurinia Pharmaceuticals Inc (AUPH) Q4 2020 Earnings Call Transcript, Aurinia Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Operational Highlights, Aurinia Pharma EPS beats by $0.15, beats on revenue, Aurinia Pharmaceuticals to Present at the SVB Leerink 10th Annual Global Healthcare Conference, Aurinia Pharmaceuticals to Release Fourth Quarter and Year End 2020 Financial Results on February 24, 2021, Attention Biotech Investors: Mark Your Calendar For February PDUFA Dates, Here's Why Everybody's Talking About Aurinia Pharmaceuticals Stock. Aurinia Announces U.S. FDA Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis (LN), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is the first FDA-approved oral therapy for LN. Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS TM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and other proteinuric kidney disease business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; and Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion. The FDA has also informed the Company that they are not currently planning to hold an advisory committee meeting to discuss the application. Aurinia has nabbed its first FDA approval with an OK for Lupkynis (voclosporin) to treat lupus nephritis, or kidney inflammation caused by systemic lupus erythematosus. Jan 23, 2021 2:51AM EST (RTTNews) - The FDA has approved Aurinia Pharmaceuticals Inc.'s (AUPH) LUPKYNIS in combination with a background immunosuppressive therapy regimen to … Multimedia components are available with this press release (link here). Also, many of the factors are beyond our control. Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Patients in the study taking LUPKYNIS also achieved a 50 percent reduction in UPCR twice as fast as SoC, and a higher portion of LUPKYNIS-treated patients achieved a complete renal response at 24 weeks compared to patients receiving SoC. Aurinia has developed voclosporin for the treatment of lupus nephritis. Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. UPCR is a standard measurement used to monitor protein levels in the kidney. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Aurinia will host a conference call and webcast to discuss the approval of LUPKYNIS on Monday, January 25, 2021 at 8:30 a.m. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (versus cyclosporine A), and an improved metabolic profile compared to legacy CNIs. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied. Advise not to breastfeed. VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)-- "We have long supported Aurinia Pharmaceuticals and are encouraged by the U.S. FDA approval of voclosporin, a much-needed oral treatment option to address the challenges faced by people living with LN.”, "New treatments indicated specifically for lupus nephritis will contribute to our quest for health equity in kidney diseases," commented National Kidney Foundation’s Chief Medical Officer Joseph Vassalotti, M.D. Next January 22, 2021 is the PDUFA where the FDA will decide the approval of … The Company is currently developing the investigational drug voclosporin for the treatment of lupus nephritis, other proteinuric diseases and dry eye syndrome. QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN and DES programs; that another company will not create a substantial competitive product for Aurinia’s LN and DES business without violating Aurinia’s intellectual property rights; the burn rate of Aurinia’s cash for operations; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or proteinuric kidney disease markets; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of other parties. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. Aurinia Pharmaceuticals advised that LUPKYNIS is now available to patients in the U.S. and the medicine now holds the distinction of being the first FDA-approved oral therapy for LN. Stock quotes by finanzen.net. In both studies, initial treatment with intravenous (IV) methylprednisolone up to a cumulative dose of 1 g was administered on Days 1 and 2, and all patients received a subsequent taper of oral corticosteroids. As many as 1.5 million Americans suffer from systemic lupus erythematosus, an autoimmune disease primarily affecting women that causes inflammation in connective tissues. Corporate, administration and business development expenses increased to $38.8 million for the three months ended December 31, 2020 compared to $7.3 million for the three months ended December 31, 2019. Use of LUPKYNIS is not recommended in this situation. The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Lupkynis FDA Approval History. Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex and autoimmune disease. Aurinia Pharmaceuticals, based in Victoria, British Columbia and Rockville, Maryland, has a target action date of January 22 for its voclosporin. Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are … The company expects to submit the voclosporin for lupus nephritis to the FDA in the first half of this year and is planning on a commercial launch in early 2021. So let's talk products, and therefore revenue, first. About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are … The company was founded by Robert Foster, Richard Glickman and Michael Martin on June 16, 1993 and is headquartered in Victoria, Canada. Aurinia Pharmaceuticals Inc. AUPH announced that the FDA has approved its new drug application (“NDA”) for Lupkynis (voclosporin) in combination with a … LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016. FinancialBuzz.com’s latest The Buzz Show: Featuring Our Corporate News Recap on “ Aurinia Pharmaceuticals Receives FDA Approval for LUPKYNIS”. Also, many of the factors are beyond our control. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. 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. Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS TM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). Aurinia Pharmaceuticals has one of the most important milestones in its history in a few weeks. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. INDICATION AND IMPORTANT SAFETY INFORMATION. (RTTNews) - Shares of Aurinia Pharmaceuticals Inc. (AUPH) have fallen nearly 35% from their 52-week high of $20.48 recorded on Feb.21, 2020, and trade around $13. The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub in Rockville, Maryland, and focuses its development efforts globally.

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