Saphnelo FDA Approval Status

In 2021, the FDA granted approval to two important targeted therapies for lupus: voclosporin for lupus nephritis and anifrolumab for systemic lupus erythematosus (SLE). These approvals marked the first lupus-specific treatments since belimumab in 2011, highlighting a significant advancement in lupus care.

With the approval of Saphnelo—the brand name for anifrolumab—comes the responsibility to adhere strictly to the FDA-approved prescribing information. This ensures safe and effective use of the drug, with specific guidelines on dosing, infusion protocols, contraindications, and monitoring requirements to mitigate risks, including infusion reactions and infections.

In this article, we will delve into the FDA approval status of Saphnelo, reviewing its approved indications, key highlights from the prescribing information, and practical considerations for its use in clinical practice.

Key Takeaways

Saphnelo (anifrolumab) received FDA approval in July 2021 as the first new treatment for systemic lupus erythematosus (SLE) in over a decade. It offers a targeted therapy for adults with moderate to severe SLE.
Saphnelo works by blocking type I interferon receptors to reduce inflammation and improve disease control.
Clinical trials such as MUSE and TULIP demonstrated the efficacy and safety of Saphnelo. These show significant improvements in disease activity, steroid reduction, and BICLA response rates.
Saphnelo is contraindicated in patients with serious infections, hypersensitivity to anifrolumab, and those receiving live vaccines.
International approvals for Saphnelo include the European Commission, Japan, and Canada. There is ongoing monitoring and research in the EU to gather real-world safety data.
AstraZeneca’s post-approval program focuses on continued pharmacovigilance. Ongoing and future trials aimed at expanding Saphnelo’s indications to treat other autoimmune diseases.

About: Medica Depot is your trusted all-in-one supplier, offering a range of high-quality medical injectables and supplies. Buy Saphnelo online at Medica Depot today! Whether for health professionals, plastic surgeons, dermatologists, licensed estheticians, or other specialists, we can offer genuine, brand-name products you may need. With Medica Depot, we prioritize serving you better to improve the patient’s quality of life.

Saphnelo FDA Approval (July 2021) and Indications

Infusion bottle with IV solution in the hospital.

Patients who have not yet received treatment for their lupus condition may be curious about Saphnelo’s FDA approval status. Fortunately, the US Food and Drug Administration (FDA) approved anifrolumab (Saphnelo’s generic name) on July 31, 2021.

This approval represents the first new therapy for systemic lupus erythematosus (SLE) in adults in over a decade. The approval followed the review of the medication’s robust efficacy and safety data from clinical trials. These include the MUSE and TULIP Phase trials.

Saphnelo works by blocking type I interferon receptors. As an effect, it reduces inflammation in adults with moderate to severe SLE who remain on standard therapy. Additionally, there are specific limitations of use for Saphnelo:

Saphnelo has not been evaluated in patients with severe active lupus nephritis.
Its use is not recommended for patients with severe, active central nervous system lupus, as there is no available efficacy and safety data.
Saphnelo should not be used beyond its approved adult SLE population. Its safety and efficacy have not been established in other groups.
Saphnelo is contraindicated for individuals with serious infections or hypersensitivity to anifrolumab.
Caution is advised in patients who are undergoing immunizations or using other biologic therapies concurrently.

Saphnelo Clinical Evidence Supporting Approval for Severe Lupus Erythematosus

A medical professional conducting a clinical trial in a laboratory.

The FDA approval of Saphnelo in July 2021 was based on the positive results from the MUSE and TULIP studies. These results showed the drug’s efficacy and safety in adults with moderate to severe SLE on standard therapy.

These randomized, placebo-controlled trials showed that Saphnelo reduced disease activity across various organs. It also allowed patients to taper steroids more consistently.

In the MUSE Phase II study, 305 adults with active SLE received either 300 mg, 1,000 mg, or a placebo via IV infusion every four weeks for 48 weeks. Patients receiving Saphnelo showed higher SRI-4 response rates and achieved greater reductions in their daily steroid doses compared to those on placebo, confirming the clinical benefit of Saphnelo.

Moreover, the TULIP Phase III trials showed the following:

TULIP-1 (150 mg or 300 mg vs. placebo) did not meet its primary SRI-4 endpoint at Week 52.
TULIP-2 (300 mg vs. placebo) achieved its primary goal, with 47.8% of Saphnelo-treated patients. They achieved a BICLA response at Week 52, compared to 31.5% on placebo (p < 0.001).

These findings highlight Saphnelo’s ability to significantly improve disease control in SLE patients, especially when used in conjunction with other therapies.

Saphnelo EMA & International Approvals for Systemic Lupus

AstraZeneca’s Saphnelo received European Commission approval in February 2022 after a positive CHMP opinion. Since then, the medication has secured global authorization for the treatment of adults with active SLE.

Key regulatory approvals include:

European Union: CHMP Positive Opinion and EC Marketing-Authorisation Decision.
United States (FDA): Approved July 2021.
Japan (Ministry of Health, Labour and Welfare): Approved September 2021.
Canada (Health Canada): Approved November 2021.

Additionally, Saphnelo is under ongoing monitoring in the EU to collect real-world safety and effectiveness data. AstraZeneca is also continuing its regulatory submissions in China, Latin America, and other regions to expand patient access.

Saphnelo Post‑Approval Label Guidance & Ongoing Trials

Medical scientists working in a clinical laboratory.

Following its approval, Saphnelo’s post-approval program combines rigorous pharmacovigilance with a robust clinical development pipeline, ensuring both ongoing safety monitoring and the exploration of new indications.

Label Maintenance: In the EU, AstraZeneca submits Periodic Safety Update Reports under the Single Assessment procedure and updates the SmPC and package leaflet as per CHMP recommendations. In the U.S., the FDA collects adverse-event data via MedWatch and requires label revisions whenever new safety signals emerge.
Regulatory Safety Activities: AstraZeneca tracks emerging evidence of efficacy and safety. It also updates prescribing information across regions based on real-world experiences.
Expansion into Other IFN-Driven Diseases: Clinical trials like LAVENDER (cutaneous lupus erythematosus), JASMINE (idiopathic inflammatory myopathies), IRIS (active proliferative lupus nephritis), DAISY (systemic sclerosis), AZALEA (SLE in China), BLOSSOM (pediatric SLE), and TULIP-SC (subcutaneous anifrolumab) are underway or planned, further expanding the therapeutic potential of Saphnelo.

Conclusion

Saphnelo’s FDA approval marks a significant milestone in the treatment of systemic lupus erythematosus (SLE). It offers a new therapeutic option for adults battling this chronic autoimmune condition. With clinical trials demonstrating its efficacy and safety, Saphnelo enables healthcare providers to better manage disease activity in SLE patients, while also reducing reliance on steroids.

As the drug gains international recognition, ongoing monitoring and continued research will be vital for understanding its long-term effects and potential in treating other autoimmune diseases. With AstraZeneca’s commitment to expanding clinical indications and patient access, Saphnelo is poised to play a key role in future lupus management.

FAQs

1. When did the FDA approve Saphnelo, and what does it treat?

The FDA approved Saphnelo (anifrolumab) on July 31, 2021. It serves as a treatment for adults with moderate to severe systemic lupus erythematosus (SLE).

2. What clinical trials supported Saphnelo’s approval?

The MUSE and TULIP II and III trials support the approval of Saphnelo. These demonstrated Saphnelo’s effectiveness in reducing disease activity and helping patients taper off steroid use.

3. Are there any limitations to Saphnelo’s use?

Yes, Saphnelo is not recommended for patients with severe active lupus nephritis or severe central nervous system lupus. It also should not be used in individuals with serious infections or those who are hypersensitive to anifrolumab.

Require assistance or custom offers?

Our sales representatives are here to help.

References

Katella K. New Lupus Treatments Offer a Better Chance for Remission. Yale Medicine. Published July 29, 2022. https://www.yalemedicine.org/news/new-lupus-treatments
HIGHLIGHTS of PRESCRIBING INFORMATION | SAPHNELO®. US Food and Drug Administration. Accessed June 27, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761123s005lbl.pdf
AstraZeneca announces start of recruitment in two new Phase III trials evaluating Saphnelo – in cutaneous lupus erythematosus (LAVENDER) and in idiopathic inflammatory myopathies (JASMINE). Astrazeneca.com. Published September 19, 2024. Accessed June 27, 2025. https://www.astrazeneca.com/media-centre/medical-releases/astrazeneca-announces-start-of-recruitment-in-2-new-phase-iii-trials-evaluating-saphnelo-in-cle-and-in-iim.html