AstraZeneca
Pharmaceutical Technology Research and Development Provider
Johnson & Johnson
Medical Device R&D and Manufacturer
GSK China
Pharmaceutical Manufacturer
Recently, global pharmaceutical giants AstraZeneca and Johnson & Johnson have announced their systemic lupus erythematosus (SLE) The latest clinical data on therapeutic drugs have injected new vitality into the treatment landscape of this autoimmune disease. AstraZeneca focuses on its own drugs.Saphnelo（anifrolumab) Subcutaneous injection new formulation, Johnson & Johnson is advancingFcRnBlockernipocalimabThe R&D progress has sparked widespread attention in the industry due to the actions of the two major pharmaceutical companies.
AstraZeneca's Saphnelo Subcutaneous Injection Phase 3 Data Shines
AstraZeneca announced this time3PeriodTULIP-SCThe full data of the study, the results of which have been published in "Arthritis & Rheumatology》Journal, and previously the EU regulatory authority hadSaphneloThe subcutaneous injection formulation lights up“Green Light”。
This inclusion367A study of patients showed that during the treatment52At the same time, based on the British Lupus Assessment Group Comprehensive Lupus AssessmentBICLAStandard, AcceptSaphneloAmong patients receiving subcutaneous injection therapy,56.2%Achieved a reduction in disease activity, while the placebo group was only37.1%. This19.1The difference of percentage points is statistically significant and consistent with the results of previous intravenous trials, confirming the stable efficacy of the drug.
In terms of key secondary endpoints,SaphneloSimilarly demonstrated“Clinically Significant”The effect:
56.2%Patients who use the medication can maintain a lower or reduced dose of oral steroids, while the placebo group cannot.34%；
41.5%The patients achieved sustained52Week'sBICLAResponse, placebo group only22.6%；
Moreover, the proportion of patients in the medication group who experienced disease recurrence within one year (40.9%) Lower than the placebo group (48.5%), but this difference did not reach statistical significance.
It is worth mentioning that,SaphneloSubcutaneous injection formulations allow patients to self-administer the drug outside of a clinical setting, marking a strategic shift in AstraZeneca's positioning for this medication.
Currently,SaphneloThe intravenous injection formulation has been launched globally70Approved in multiple countries for the treatment of moderate to severe systemic lupus erythematosus, its subcutaneous injection formulation is currently under regulatory review in the United States and Japan.
If successfully approved, this formulation will be with GSK ChinaBenlysta（belimumab) Engage in direct competition.BenlystaSubcutaneous injection form of2017Year Based onBLISS-SCThe study, which has received approvals from both the United States and Europe, shows that52Weektime60.8%of patients achieved the Systemic Lupus Erythematosus Responder Index (SRI) responded, placebo group was48.5%。
Johnson & Johnson's Nipocalimab Phase 2b Data Positive, Plans to Initiate Phase 3
At the same time, Johnson & Johnson announced itsnipocalimabDrug-related2bPeriodJASMINEStudy Positive Topline Data, Announcing the Drug as the First to Show Therapeutic Activity in Active Systemic Lupus ErythematosusFcRnBlockers.
This inclusion228The study involving [number] patients met the primary endpoint:
Treatment24At the same time, achieveSRI-4The proportion of patients responding was significantly higher than in the placebo group.
In addition, the drug also met key secondary endpoints and exploratory endpoints, including demonstrating a potential steroid-sparing effect.
Based on this positive result, Johnson & Johnson stated that it will initiatenipocalimabFor the treatment of systemic lupus erythematosus3Phase clinical trial project. It is worth noting that the drug has been approved last year.FDAApproval, toImaavyFor the brand name used to treat generalized myasthenia gravis.
Except for systemic lupus erythematosus,nipocalimabJohnson & Johnson has also been advancing research and development in multiple autoimmune disease fields, including Hemolytic Disease of the Fetus and Newborn (HDFN), Warm Antibody Autoimmune Hemolytic Anemia (WAIHA), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Sjögren's Syndrome. However, last year, due to unsatisfactory results, Johnson & Johnson discontinued...nipocalimabMid-term Combination Trial in Rheumatoid Arthritis.
Latest Developments from Two Major Pharmaceutical Companies Bring New Hope for Systemic Lupus Erythematosus Patients, Intensifying Market Competition in the Field. Subsequently,SaphneloThe regulatory approval process for subcutaneous injectable formulations andnipocalimabThe3The results of the study will continue to be the focus of industry attention.
Reference:FirstWorld Pharma
