百健免疫学和新疾病领域部门负责人亚当·迈尔斯(Adam Myers)在数据公布前的一次采访中表示，尽管一些新疗法获得批准，患者取得了实质性进展，但未满足的需求仍然存在。迈尔斯补充称，他们经常听到关于疗效不显著或起效较慢的评论，他们的目标是尝试为患者改善治疗选择。Biogen and its Belgian partner UCB announced on Tuesday that their experimental lupus treatment drug, dapilumab, met its primary endpoint in late-stage trials.
According to the Securities Times, Biogen (BIIB.US) and its Belgian partner UCB announced on Tuesday that their experimental lupus treatment drug, dapilumab, met its primary endpoint in late-stage trials. This surprising result reversed the failure in the early and mid-term studies of the drug. If this success is confirmed in the second late-stage study, it could provide new treatment options for lupus patients, especially in a field where trial failures and approved therapies are very limited. The two companies plan to initiate the second study later this year.
The two companies stated that in a trial involving 321 patients, dapilumab, when taken with corticosteroids and immunosuppressive drugs, showed significantly reduced disease activity compared to a placebo. It is understood that lupus is a disease that mainly affects women, is unpredictable, and causes a range of symptoms. Approved treatments include Astrazeneca's Saphnelo (AZN.US) and GlaxoSmithKline's Benlysta (GSK.US).
Adam Myers, Head of Immunology and Emerging Diseases at Biogen, stated in an interview before the data was released that despite some new therapies gaining approval and patients making substantial progress, unmet needs still exist. Myers added that they often hear comments about lack of significant efficacy or slow onset of action, and their goal is to try to improve treatment options for patients.
The drug is being tested on patients with the most common type of lupus - systemic lupus erythematosus, where the immune system attacks the body's own tissues and can lead to organ failure. According to federal data, about 0.2 million patients in the USA have this disease.
Due to the Biogen-UCB drug not achieving its primary endpoint in a mid-term trial for patients with moderate to severe active disease in 2018, most Wall Street analysts have removed this drug from sales forecasts.
In contrast, Astrazeneca's Saphnelo was approved in 2021, achieving sales of $0.28 billion in 2023, while GlaxoSmithKline's Benlysta was first approved in 2011, with sales reaching €1.35 billion (1.5 billion USD) last year. Several other pharmaceutical companies are also developing experimental lupus drugs.
