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Aurinia Pharmaceuticals & A Potential Blockbuster Lupus Drug

Aurinia Pharmaceuticals & A Potential Blockbuster Lupus Drug

Aurinia Pharmaceuticals & A Potential Blockbuster Lupus Drug In January 2021, the FDA approved Aurinia’s drug for treatment for lupus nephritis, Voclosporin, making it only the second drug approved by the FDA for lupus nephritis (LN), after GSK’s “Grand Slam” drug Benlysta in December 2020, though Benlysta has been used to treat lupus (systemic lupus erythematosus) since 2011. (1)

Lupus (SLE) and lupus nephritis are distinct, with lupus being the autoimmune disease itself and lupus nephritis being when lupus has begun doing damage to the kidneys, with Voclosporin being approved for specifically lupus nephritis. Moreover, there are about 80,000 to 100,000 cases of lupus nephritis in the US and 1 million worldwide. (2) 

Voclosporin is an immunosuppressive and seems to be used in cases where less aggressive methods have failed; immunosuppressives are prescribed for lupus when patients haven’t responded to steroid treatments or can’t take high doses of steroids. 

The other drugs in the immunosuppressive category with Voclosporin for treating lupus are chemotherapy drugs or a drug designed to prevent rejection during kidney transplants, and all have serious side effects (as you would expect from chemo drugs). 

The drug that Voclosporin is most likely to compete with is probably Benlysta, the only other drug approved specifically for lupus nephritis. It is categorized as a monoclonal antibody: a type of protein designed in the lab to find and attach to only one type of substance in the body.

Benlysta interferes with a protein required in B cell activity, which is one kind of immune response cell that is overactive when someone has lupus. For both Voclosporin and Benlysta, there doesn’t seem to be any serious side effects. (3) 

According to the Pharma Times, Benlysta should hit $4 billion in 2022 sales, whereas Voclosporin saw first quarter, 2021 sales of less than $1 million. 

Among doctors who specialise in treating lupus nephritis and other kidney diseases.

Most of the attention focuses on Benlysta and Voclosporin. For being their drugs of choice for treating lupus nephritis.

Additionally, this usually favors one or the other. But, there is some suggestion that both can be used together as treatment. 

There is an expectation of an uptake of Voclosporin over time. However, Benlysta does have an advantage for having been around longer. Moroever, some doctors were prescribing Benlysta for LN during a period the medication only had approval for lupus. (4)

Aurinia is also in a collaboration and license agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of Voclosporin for the treatment of Lupus Nephritis in the European Union.

Furthermore, Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine. Secondly, as part of the agreement, Aurinia will receive an upfront cash payment of $50 million U.S. and has the potential to receive up to $50 million U.S. in regulatory and reimbursement milestone payments. 

In conclusion Aurinia will receive tiered royalties ranging from 10 to 20 percent. Additionally, this is dependent on achievement of sale milestones on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka. In addition, Otsuka is planning to seek approval for Voclosporin in the EU in the second quarter of 2021 and in Japan next. Lastly, Aurinia’s cash and equivalents totaled $421 million as of September 30, 2020. Aurinia expects to have suffficent cash through the end of 2022. (5)

Aurinia Pharmaceuticals & A Potential Blockbuster Lupus Drug written by Bill Xuan

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Works Cited For Aurinia Pharmaceuticals & A Potential Blockbuster Lupus Drug

(1). Retrieved from https://www.drugs.com/history/lupkynis.html

(2). Retrieved from https://www.zyversa.com/pipeline/about-lupus-nephritis

(3). Retrieved from https://www.lupus.org/resources/medications-used-to-treat-lupus

(4). Retrieved from https://www.prnewswire.com/news-releases/on-the-heels-of-recent-fda-approvals-glaxosmithklines-benlysta-belimumab-and-aura-pharmaceuticals-lupkynis-voclosporin-emerge-as-practical-and-effective-tools-in-the-treatment-of-lupus-nephritis-301246136.html

(5). Retrieved from https://ir.auripharma.com/press-releases/detail/208/aurinia-announces-collaboration-and-licensing-agreement