Incurable Lupus Nephritis Treatment Designated for Priority Review by US FDA

Lupus Nephritis Treatment 'Boclosporin' Targeted for Approval in January Next Year and Commercialization in Q1

[Asia Economy Reporter Kim Jong-hwa] The commercialization timeline for the treatment of the intractable disease lupus nephritis (LN) is expected to be significantly accelerated.

On the 30th, Iljin Group announced that the Canadian pharmaceutical company Orinia's lupus nephritis treatment drug, voclosporin, which has applied for new drug approval to the U.S. Food and Drug Administration (FDA), has been designated as a Priority Review candidate.

The FDA also decided not to hold a committee meeting to gather opinions from external experts and evaluation agencies before approval, giving further momentum to the approval and commercialization of the lupus nephritis treatment.

Orinia is a Canadian pharmaceutical company listed on the U.S. Nasdaq and the Toronto Stock Exchange (TSX) in Canada, with Iljin Group affiliate Iljin S&T as its largest shareholder.

With the FDA designating voclosporin as a Priority Review candidate, the final review and approval results will be announced in January next year. The review period for Priority Review drugs is about six months, which is four months faster than the general review period of 10 months. The FDA designates Priority Review status when a drug is expected to provide significant improvements in the safety and effectiveness of preventing, diagnosing, or treating serious diseases.

Voclosporin was already designated as a 'Fast Track' treatment drug by the FDA in 2016 during the clinical trial phase, allowing frequent meetings with the FDA and guidance until the submission of new drug approval application data after Phase 3 clinical trials.

Peter Greenleaf, CEO of Orinia, said, "Patients suffering from lupus nephritis need treatments that can rapidly alleviate the disease and prevent kidney damage," adding, "We will cooperate as much as possible during the FDA review period to commercialize the drug in the first quarter of 2021."

Lupus nephritis occurs when systemic lupus erythematosus (SLE, hereafter lupus) invades the kidneys. Lupus is an inflammatory disease caused by autoantibodies produced to combat immune diseases, which become abnormally activated in organs such as the kidneys, lungs, heart, as well as in the circulatory and nervous system tissues.

There are 5 million lupus patients worldwide. Among them, 2 million (40-50%) progress to lupus nephritis, which is an intractable disease where 87% of patients develop end-stage renal failure or die within 10 years without proper treatment.

Until now, there has been no FDA or European EMA-approved treatment for lupus nephritis, so patients have been treated with CellCept (MMF), a drug that alleviates rejection reactions occurring during organ transplantation, combined with steroids. However, only 10-20% of patients responded effectively, while the rest experienced side effects such as cataracts or worsening hip joints due to steroid use.

The situation improved with the results of Phase 3 clinical trials. Among those administered voclosporin, 40.8% met the treatment goals, and no adverse effects or abnormal signs such as blood pressure or diabetes were observed, attracting attention from the medical community.

An Iljin Group official said, "The global lupus medical community has noted that the Phase 3 clinical trial subjects were not limited to a specific country but spanned 27 countries worldwide, and the Phase 3 results showed treatment effects regardless of race, age, or region, raising great expectations for the commercialization of the new drug."

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