Big pharma wins first FDA approval for systemic lupus drug in a decade

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https://www.biopharmadive.com/news/astrazeneca-lupus-saphnelo-fda-approval/604291/​

AstraZeneca wins first FDA approval for systemic lupus drug in a decade​

Published Aug. 2, 2021

 

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Dive Brief:​

• The Food and Drug Administration has approved AstraZeneca's drug Saphnelo for the treatment of systemic lupus, the British pharma announced Monday, making the antibody the first new drug cleared for the autoimmune condition since GlaxoSmithKline won approval for Benlysta in 2011. Saphnelo is the first drug of its type, designed to block an immune-activating protein called type 1 interferon.
• Approval came despite Saphnelo failing one of two pivotal trials that aimed to show treatment could reduce disease activity and organ damage in patients. The FDA often requires drugs to have two successful trials before granting final approval for a drug.
• Patient advocacy groups supported the FDA's decision, which comes six months after the agency cleared another drug, Aurinia Pharmaceuticals' Lupkynis, for a kind of kidney disease caused by lupus.

 

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Dive Insight:​

Benlysta's approval was itself a landmark, being the first such drug approved in decades. Its use has grown slowly and steadily over time, falling just shy of blockbuster sales last year.
The drug's market is expected to expand rapidly, however. Consultants Global Data forecast global sales of lupus drugs amounting to $1.6 billion in 2028, a 6% annual growth rate, as Saphnelo reaches the market and other drugs gain approval. Numerous drugs are in development to treat lupus, including Eli Lilly's Olumiant, Roche's Gazyvaro and the experimental agent dapirolizumab from UCB.
Saphnelo looked like it might not advance to market when the pivotal TULIP 1 trial failed to meet its primary goal in 2018. However, a year later a second trial called TULIP 2 succeeded using another endpoint that included more components. In that study, 48% of patients randomized to take Saphnelo were defined as responders, significantly more than the 32% in the group given placebo.
Significantly more patients taking Saphnelo reduced their use of steroids to control disease symptoms, as well as experienced reduction in skin disease. However, treatment didn't decrease the number of swollen or tender joints reported.
AstraZeneca didn't announce when Saphnelo will launch or what price it will set. A spokesperson didn't respond to BioPharma Dive's request for comment.
GlaxoSmithKline charged Medicare about $28,000 per patient on Benlysta, although that figure doesn't include any manufacturer rebates.

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  BIOPHARMA DIVEFDA approves first-of-its-kind lupus drug

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Recommended Reading:​

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  BIOPHARMA DIVEFDA approves first-of-its-kind lupus drug

Follow Jonathan Gardner on Twitter

Dive Insight:​

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, immunosuppressants, steroids 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.

 

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FDA approves first-of-its-kind lupus drug​

Published Jan. 25, 2021

Jacob BellSenior Reporter

Dollar Photo Club

Dive Brief:​

• 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.

 

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Lupus​

From Wikipedia, the free encyclopedia

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This article is about the most common type of lupus. For the broader group of diseases known as "lupus", see Lupus erythematosus.
"SLE" redirects here. For other uses, see Lupus (disambiguation) and SLE (disambiguation).

Lupus
Other names	Systemic lupus erythematosus (SLE)
Young woman with the typical butterfly rash found in lupus
Pronunciation	/sɪˈstɛmɪk ˈluːpəsˌɛrɪθiːməˈtoʊsəs/ (listen) sih-STEM-ik LOOP-əs ERR-i-thee-mə-TOH-səs
Specialty	Rheumatology
Symptoms	Painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, red rash[1]
Usual onset	15–45 years of age[1][2]
Duration	Long term[1]
Causes	Unclear[1]
Diagnostic method	Based on symptoms and blood tests[1]
Medication	NSAIDs, corticosteroids, immunosuppressants, hydroxychloroquine, methotrexate[1]
Prognosis	15 year survival ~80%[3]
Frequency	2–7 per 10,000[2]

Lupus, technically known as systemic lupus erythematosus (SLE), is an autoimmune diseasein which the body's immune systemmistakenly attacks healthy tissue in many parts of the body.[1]Symptoms vary between people and may be mild to severe.[1] Common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rashwhich is most commonly on the face.[1] Often there are periods of illness, called flares, and periods of remission during which there are few symptoms.[1]

 

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The cause of SLE is not clear.[1] It is thought to involve genetics together with environmental factors.[4] Among identical twins, if one is affected there is a 24% chance the other one will be as well.[1] Female sex hormones, sunlight, smoking, vitamin D deficiency, and certain infections are also believed to increase the risk.[4] The mechanism involves an immune response by autoantibodies against a person's own tissues.[1] These are most commonly anti-nuclear antibodies and they result in inflammation.[1] Diagnosis can be difficult and is based on a combination of symptoms and laboratory tests.[1] There are a number of other kinds of lupus erythematosus including discoid lupus erythematosus, neonatal lupus, and subacute cutaneous lupus erythematosus.[1]

 

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There is no cure for SLE.[1] Treatments may include NSAIDs, corticosteroids, immunosuppressants, hydroxychloroquine, and methotrexate.[1] Although corticosteroids are rapidly effective, long-term use results in side effects.[5] Alternative medicine has not been shown to affect the disease.[1] Life expectancy is lower among people with SLE.[6] SLE significantly increases the risk of cardiovascular disease with this being the most common cause of death.[4] With modern treatment about 80% of those affected survive more than 15 years.[3]Women with lupus have pregnancies that are higher risk but are mostly successful.[1]