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EMA’s CHMP recommends approval for AstraZeneca’s Saphnelo to treat SLE Pharmaceutical-Business-Review
December 22, 2021
A fully human monoclonal antibody, Saphnelo targets subunit 1 of the type one interferon (type 1 IFN) receptor, blocking the type 1 IFN’s activity.
Saphnelo Recommended for Approval in the EU by CHMP for the Treatment of Patients with Systemic Lupus Erythematosus AmericanPharmaceuticalReview
December 21, 2021
AstraZeneca’s Saphnelo (anifrolumab) has been recommended for marketing authorization in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe...
CHMP recommend Saphnelo for systematic lupus erythematosus pharmatimes
December 21, 2021
With approval, Saphnelo would be the first available treatment for systematic lupus erythematosus in Europe in over ten years.
CAR T-Cell Immunotherapy Rids Woman of Tough-to-Treat Lupus drugs
August 06, 2021
In a first, researchers have used genetically tweaked immune system cells to send a woman's severe lupus into remission.
Saphnelo Approved in US for Moderate to Severe Systemic Lupus Erythematosus americanpharmaceuticalreview
August 04, 2021
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
AZ’s Saphnelo scores US approval for systemic lupus erythematosus pharmatimes
August 03, 2021
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Saphnelo (anifrolumab) for the treatment of moderate to severe systemic lupus erythematosus (SLE).
FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus drugs
August 03, 2021
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
I-Mab Announces China NMPA Approval for Phase 1b Trial of Felzartamab in Systemic Lupus Erythematosus prnasia
June 28, 2021
I-Mab, a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has ...
PPD, Clinical Ink Partner on Near Real-Time Access to Endpoint Data contractpharma
March 25, 2021
PPD, Inc., a global CRO, and Clinical Ink, a global clinical technology company, have jointly developed a systemic lupus erythematosus (SLE) assessment review process designed to simplify operationalizing clinical trials for this chronic autoimmune ...
Exagen, GSK Partner to Raise Lupus Diagnosis, Management Awareness americanpharmaceuticalreview
November 26, 2020
Exagen has extended its collaboration agreement with GlaxoSmithKline (GSK) to raise awareness of the importance of timely diagnosis of systemic lupus erythematosus (SLE), the most common and severe form of lupus.

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