- For the first time, the Food and Drug Administration has approved an oral medicine for a kidney disease that is caused by lupus and can lead to kidney failure, heart complications and death.
- The medicine, now known as Lupkynis, is given alongside immunosuppressants to treat adults with active lupus nephritis. Its developer, Aurinia Pharmaceuticals, has set a list price of $3,950 for a "wallet" of 60 capsules. A spokesperson for Aurinia said each wallet would last for 10 days based on the approved dosing protocol, and the company expects average net revenue from Lupkynis to be approximately $65,000 per patient per year.
- While such a high list price might be met with pushback, Aurinia said it has been laying the groundwork for a large commercial launch. In a Monday presentation to investors, the company said it's assembled a team experienced at selling drugs for the immune system and kidneys. The team has identified around 12,000 physicians to target in the Lupkynis rollout, and has conducted pre-approval information exchanges with more than 50 payers covering two-thirds of commercially insured lives, according to Aurinia.
While estimates vary, the Lupus Foundation of America figures that 1.5 million people in the U.S. and at least 5 million people worldwide are affected by the autoimmune disease. Despite the prevalence of the condition, however, there remains relatively few new treatment options.
Historically, repurposed anti-inflammation drugs, steroids, immunosuppressants and antimalarials like hydroxychloroquine have been used to manage lupus symptoms. But it wasn't until 2011 that a drug specifically developed for the disease, GlaxoSmithKline's Benlysta, became available.
Benlysta is an antibody therapy given through an intravenous injection. In December, it also became the first FDA-approved drug for adults with active lupus nephritis, which affects about 50% of the people with lupus. Over the first nine months of 2020, GSK recorded 514 million pounds, or roughly $700 million, in Benlysta sales, a 17% increase from the same period a year prior.
Now, there's another available treatment in Lupkynis.
"For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic," said Brad Rovin, director of the nephrology division at Ohio State University's Wexler Medical Center, in a statement from Aurinia.
The Lupkynis approval "allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate," Rovin added.
The FDA's decision was informed by one mid-stage and one late-stage clinical trial, both of which tested Lupkynis against placebo.
The late-stage study found that after one year of treatment, significantly more participants achieved a complete kidney response when given Aurinia's drug and standard therapy, as opposed to a placebo and typical treatment. Participants receiving Lupkynis also achieved certain measures of kidney health faster than their placebo-treated counterparts.
There was a list of adverse reactions that happened more often to Lupkynis-treated patients, however. The most common were headache, diarrhea, hypertension and decreased kidney filtration rates.
Lupkynis also carries a boxed warning for increased risk of developing malignancies and serious infections.
Aurinia's share price opened at $20.50 Monday morning, up 38% from Friday, before falling back to trade at about $18.