Aurinia Pharmaceuticals Inc (AUPH)

[moosedogger]

Excellent summary- from 'Biospace' 3 days ago


Aurinia Pharmaceutical’s Voclosporin for Lupus Nephritis

Aurinia Pharmaceuticals, based in Victoria, British Columbia and Rockville, Maryland, has a target action date of January 22 for its voclosporin. The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE).

“People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage,” said Peter Greenleaf, president and chief executive officer of Aurinia, in July 2020 when the FDA accepted the NDA to review. “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.”

The FDA granted the NDA Priority Review, which expedited the review from the typical 10 months to six months. The NDA was supported by results from two pivotal trials, Phase III AURORA and Phase II AURA-LV.

Voclosporin is a novel and potentially best-in-class calcineurin inhibitor (CNI). It acts as an immunosuppressant, with a synergistic and dual mechanisim of action. By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. As a result, it stabilizes the podocyte in the kidney.

On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. to develop and commercialize oral voclosporin for LN in the European Union, Japan, as well as the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

Only two days earlier, on December 15, Aurinia expanded an exclusive manufacturing relationship with Switzerland’s Lonza to build a dedicated manufacturing capacity within Lonza’s existing small molecule API facility in Visp, Switzerland. The factory will be set up to manufacture voclosporin, while expanding existing capacity and providing supply security for future commercial demand.

https://www.biospace.com/article/fda-action-alert-merck-aurinia-and-amgen/