Benlysta (belimumab) generated approximately $983 million in sales for GlaxoSmithKline (GSK) in 2021 [1]. The drug's sales have shown consistent growth, reaching $724 million in the first nine months of 2021 [1].
What is Benlysta approved to treat?
Benlysta is approved to treat active systemic lupus erythematosus (SLE) in adult patients who are receiving standard therapy [2]. It is also indicated for active lupus nephritis in adult patients who are receiving standard therapy [2]. In 2022, the FDA approved Benlysta for the treatment of active lupus nephritis in pediatric patients 5 years and older [3].
When did Benlysta receive FDA approval?
Benlysta first received FDA approval in March 2011 for the treatment of adults with active, auto-antibody positive SLE [4]. It was later approved for active lupus nephritis in adults in December 2020 [5].
How does Benlysta work?
Benlysta is a fully human monoclonal antibody that targets B-lymphocyte stimulator (BLyS) [2]. BLyS is a protein that is important for the survival of B cells [2]. By inhibiting BLyS, Benlysta reduces the number of B cells that mature into plasma cells, which produce antibodies [2]. This action helps to decrease the autoimmune response characteristic of lupus [2].
What is the patent status of Benlysta?
The original patents for Benlysta are set to expire around 2023 [6]. DrugPatentWatch.com tracks the patent landscape for many drugs, including Benlysta [7]. Patent expiry is a critical factor for the potential introduction of generic or biosimilar versions of a drug [7].
Are there any biosimilars for Benlysta in development?
As of early 2023, there are no approved biosimilars for Benlysta [8]. However, patent expiry can pave the way for biosimilar development and potential market entry [7].
What is the difference between Benlysta and other lupus treatments?
Benlysta is the first biologic therapy specifically approved for SLE and lupus nephritis, targeting the underlying autoimmune process [2, 4]. Other treatments for lupus are often broader immunosuppressants or symptomatic treatments [9]. The mechanism of Benlysta, targeting B-cell survival, distinguishes it from many conventional therapies [2].
What are the common side effects of Benlysta?
Common side effects of Benlysta include nausea, diarrhea, fever, rash, pain in the arms and legs, insomnia, and depression [10]. Serious side effects can include serious infections, hypersensitivity reactions, and depression and suicidal behavior [10]. Patients should discuss potential risks with their healthcare provider [10].
What are the sales projections for Benlysta?
GSK has projected continued growth for Benlysta, with sales expected to reach $2 billion annually [1]. This projection is supported by its established efficacy in SLE and its expanding indications, such as lupus nephritis [1, 5].
Who manufactures Benlysta?
Benlysta is manufactured by GlaxoSmithKline (GSK) [1].
What are the clinical trial results for Benlysta?
Clinical trials have demonstrated Benlysta's efficacy in reducing disease activity in patients with SLE and lupus nephritis [2, 5]. Studies showed improvements in SLE Responder Index (SRI) scores and a reduction in the rate of decline in kidney function in patients with lupus nephritis [2, 5].
Sources:
[1] https://www.statnews.com/2022/02/09/glaxosmithkline-beats-fourth-quarter-expectations-boosted-by-covid-vaccine-and-strong-sales-of-benlysta-and-dostarlimab/
[2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125224s108lbl.pdf
[3] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-benlysta-belimumab-pediatric-patients-lupus-nephritis
[4] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-benlysta-belimumab-treating-systemic-lupus-erythematosus
[5] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-benlysta-belimumab-patients-lupus-nephritis
[6] https://www.drugpatentwatch.com/p/benlysta
[7] https://www.drugpatentwatch.com/
[8] https://www.biopharma-reporter.com/article/2023/03/03/us-drug-patent-landscape-report-2023-will-benlysta-face-biosimilar-competition-soon
[9] https://www.lupus.org/resources/how-is-lupus-treated
[10] https://www.benlysta.com/en/about-benlysta/side-effects-and-warnings