dm+d

Unassigned

New Medicines

Lupkynis (US)Lupus nephritis - as an adjunct to use with mycophenolate

Information

Lupkynis (US)
New molecular entity
Otsuka
Aurinia

Development and Regulatory status

None
Pre-registration (Filed)
Launched
Jun 21Filed in EU via centralised procedure for treatment of lupus nephritis [21].
Jan 21LUPKYNIS is now commercially available in the U.S. [19].
Jan 21Voclosporin licensed to Otsuka Pharmaceutical in Japan and Europe [18].
Jan 21Aurinia Pharmaceuticals plans to launch voclosporin for LN in US in Q1 2021. Otsuka Pharmaceutical plans to file to EMA Q2 2021 [18].
Jan 21U.S. FDA has approved voclosporin in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis [17].
Dec 20Aurinia will work with Otsuka Pharmaceutical Co. to develop and commercialise oral voclosporin for LN in the EU UK and other countries. [16]
Jul 20FDA accepts NDA for voclosporin for lupus nephritis for priority review, with a PDUFA of 22/1/21 [15].
May 20Aurinia Pharmaceuticals intent to file an MAA with the EMA by the end of the first quarter of 2021 [14].
Mar 20Aurinia Pharmaceuticals initiate rolling submission of NDA to FDA [13].
Oct 19Aurinia Pharmaceuticals announce intention to submit rolling NDA for Lupus nephritis in the first half of 2020. With plans to launch in early 2021 [12].
Apr 17Company announces that following discussion with regulatory agencies, they believe that in conjunction with data from the AURA PIIb study, a single multinational PIII trial (AURORA, NCT03021499) will provide sufficient data for registration in the US, EU, and Japan [6,7].
Mar 16Fast-track status granted by FDA [4].

Category

Calcineurin inhibitor
In 2001, prevalence of lupus nephritis was estimated at 4.4 per 100,000 UK population [1].
Lupus nephritis - as an adjunct to use with mycophenolate
Oral

Trial or other data

May 21PIII AURORA RCT (n=179) found addition of voclosporin to mycophenolate mofetil (MMF) and low-dose steroids led to superior complete renal response rate at week 52 vs MMF and low dose steroids (41% vs 23%; OR 2.65; 95% CI 1.64–4.27; p<0.0001) [20].
Dec 19PIII AURORA trial (n=357) meets primary endpoint. Renal response rate was 40.8% for voclosporin with mycophenolate and low-dose corticosteroids vs. 22.5% for the control group [11].
May 18PIII AURORA trial is now expected to complete collection of primary outcome data in Dec 19 [9].
Apr 18PIII AURORA II trial (EURDRCT2016-004046-28) starts to assess the long-term safety and efficacy of voclosporin compared with placebo in patients with active lupus nephritis [10].
Jan 18PIII AURORA trial (NCT03021499) is recruiting; timescales unchanged [8].
Sep 16Aurinia follows up on topline data from its PIIb trial with publication of details of secondary endpoints. The trial of voclosporin hit all of its 24-week secondary endpoints, despite deaths in the treatment arms casting a shadow over the data. Both the low and high doses of voclosporin beat the control in time to complete remissions, respectively taking 19.7 and 23.4 weeks while the other cohort failed to generate a figure. More patients in the voclosporin arms achieved partial remission--70% and 66% compared to 49% in the control group--and took less time to reach this state. With the treatment arms also besting the control group in terms of reducing the urine protein/creatinine ratio (UPCR) and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, Aurinia claimed a clean sweep of secondary endpoints to go with the complete remission success it reported for the lower dose last month. The success of the lower dose of voclosporin in inducing complete remission meant the study met its primary endpoint in the topline data readout. But that success was overshadowed by deaths in the treatment arm [5].
Nov 15Aurinia announce that their independent Data and Safety Monitoring Board (DSMB) recommend continuation of the PIIb AURA-LV trial without any modifications [3].
Feb 15Aurinia initiate open-label, exploratory Aurinia early Urinary protein Reduction Predicts Response (AURION) study to assess short term predictors of response with voclosporin with mycophenolate mofetil in pts with active lupus nephritis. The trial will examine biomarkers of disease activity at 8 weeks and their ability to predict response at 24 and 48 weeks. Enrolment of patients is underway in Malaysia and is expected to be completed by Q3 of 2015. AURION study data are expected early in 2016 [2,3]
Jun 14Aurinia initiate a global, randomised, double-blind PIIb, 24 week trial of voclosporin in 258 pts with lupus nephritis (AURA-LV; NCT02141672). It will compare two doses of voclosporin (23.7mg and 39.5mg) administered with mycophenolate mofetil (MMF) vs. MMF alone. All patients will also receive oral corticosteroids as background therapy to induce and maintain remission. Enrolment is expected to be completed by the end of 2015 [2,3].

Mild to moderate dry eye syndrome

Information

New formulation
Aurinia
Aurinia

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Nov 20Development for dry eye syndrome has been discontinued after voclospoirin failed to meet primary endpoint of the Audrey trial.

Category

Aqueous, preservative free nanomicellar ophthalmic solution; topical calcineurin inhibitor type immunosuppressant
Dry eye syndrome is estimated to affect between 5% and 33% of the adult population worldwide . Dry eye syndrome is more common in people aged 50 years or older, in females and in those who have had refractive surgery [3].
Mild to moderate dry eye syndrome
Topical