'FDA rejects AZ's subQ Saphnelo, but company expects quick turnaround for new approval decision'

 AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version of lupus treatment Saphnelo.

The FDA has sent the British drugmaker a complete response letter, rejecting its application that would allow patients to self-administer the monoclonal antibody by way of a prefilled pen, the drugmaker said in a Feb. 3 press release. 

While AZ did not specify the reason for the rejection, it did say that it has provided information the regulator requested and is “committed to working with the FDA to progress the application as quickly as possible.”

Even with the CRL, the company said it still expects a decision on its updated Saphnelo SC application in the first half of this year.

The rejection comes after the European Medicines Agency signed off on the prefilled pen in December. The advancement gives patients a convenient alternative to traveling to a doctor's office for infusions every four weeks.

It also comes after AZ strengthened its case for approval last month, presenting results from a trial that showed Saphnelo SC provided a statistically significant and clinically meaningful reduction in disease activity compared with placebo, with an efficacy and safety profile consistent with its intravenous version of Saphnelo, the company said. The study also showed that the treatment helped patients reduce their use of oral corticosteroids.

There was little reaction in the market to the setback as AZ’s share price increased by less than 1% on Tuesday morning.

The FDA originally approved Saphnelo in 2021 as the first new treatment in a decade for systemic lupus erythematosus (SLE) and a challenger to GSK’s Benlysta. The U.K. rival gained an FDA nod for its subcutaneous version of Benlysta in 2017.

GSK's BlyS inhibitor generated sales of 2.7 billion pounds sterling ($3.7 billion) in the first nine months of 2025, compared with $483 million for Saphnelo in the same period. GSK’s sales of Benlysta have also been impacted positively by label expansions starting in 2020 to treat lupus nephritis. 

More than 3.4 million people in the world have SLE. It primarily affects women, causing pain, rashes, fatigue, swelling in joints and fevers. In Europe, people with SLE have a two to three times increased risk of death compared to the overall population, AZ has said. Oral corticosteroids provide relief but do not target the underlying drivers of the disorder.

Meanwhile, Spherix Global Insights analysts note that the lupus treatment landscape is “poised for evolution,” citing Biogen’s experimental litifilimab as an “especially strong competitor” to Benlysta and Saphnelo.

AZ gained worldwide rights to Saphnelo in a 2004 licensing and collaboration agreement with Medarex, which was acquired by Bristol Myers Squibb in 2009. Under the agreement, which was updated last year, AstraZeneca pays BMS a mid-teens royalty on U.S. sales.

https://www.fiercepharma.com/pharma/fda-gets-under-az-skin-rejection-its-subcutaneous-version-saphnelo