Tuesday 03/February/2026 – 02:23 PM
Company announced AstraZenecaToday, Tuesday, the US Food and Drug Administration (FDA) rejected its request to obtain approval for an easier-to-use version of the lupus treatment “Savnilo,” which pushed the potential timeline for its approval to the first half of 2026.
America rejects the easiest-to-use AstraZeneca drug to treat lupus
According to what was published in Reuters, this decision comes despite the European Union’s recent approval of the “Savnilo” formulation, which is given subcutaneously to adult patients with moderate to severe systemic lupus erythematosus, a disease that affects more than 3.4 million people around the world.
Following the announcement, shares of the Anglo-Swedish pharmaceutical company fell more than 1.5% at the beginning of the trading session, after the company explained that the Food and Drug Administration had issued what is known as a “full response letter” regarding the subcutaneous version of the drug.
This new formulation is more convenient for patients, as it allows the drug to be self-administered at home, instead of receiving it via intravenous infusion in clinics or hospitals.
AstraZeneca said that it later provided the additional information requested by the US administration, stressing that it will continue to work with the regulatory body to push the request forward. In contrast, the intravenous version of “Savnilo”, approved in more than 70 countries, is still available on the market.
Reducing the activity of lupus erythematosus
The Food and Drug Administration’s rejection came despite the drug achieving its primary goal in an advanced clinical trial, where it showed the ability to significantly reduce the activity of lupus erythematosus. The disease is considered a chronic autoimmune disease, in which the immune system attacks the body’s healthy tissues, and in some cases it may lead to organ failure.
In a related context, AstraZeneca is working to expand the use of “Savnilo” through ongoing clinical trials that include other chronic diseases, including cutaneous lupus erythematosus, polymyositis, systemic sclerosis, and lupus nephritis.
Under an updated licensing agreement in 2025, AstraZeneca will pay Bristol-Myers Squibb royalties on sales of Savinilo in the United States. The drug generated revenues of $483 million for AstraZeneca during the first nine months of 2025, representing about 1% of the company’s total revenues during that period.
