AstraZeneca Stock Dips After FDA Rejects Lupus Drug Form

FDA Rejects AstraZeneca's Saphnelo Injection

AstraZeneca PLC stock declined 1.5% after the U.S. Food and Drug Administration rejected the company's application for a subcutaneous injection form of its lupus drug, Saphnelo. The agency issued a complete response letter, indicating the new drug application cannot be approved in its current form.

Overview of the Regulatory Decision

The regulatory setback concerns a new method of administration for Saphnelo, which treats systemic lupus erythematosus. While the subcutaneous injection is delayed in the U.S., the drug remains commercially available in its approved intravenous infusion form. The original application was supported by data from the Phase III TULIP-SC trial, which met its primary endpoint.

Market Impact and Company Outlook

Following the news, AstraZeneca's stock experienced a minor downturn. The company stated it has provided the FDA with the requested information and is working to advance the application. A final decision on the updated submission is anticipated in the first half of 2026. Despite the U.S. delay, the subcutaneous version of Saphnelo is already approved in the European Union.

Summary and Next Steps

The FDA's decision represents a temporary hurdle for AstraZeneca's Saphnelo expansion plans in the U.S. market. The company's immediate focus is to work with the regulator to address the issues. Meanwhile, the drug continues to be a key treatment option globally, with over 40,000 patients treated worldwide.

FAQ

Q: Why did the FDA reject the Saphnelo injection?
A: The FDA issued a complete response letter, indicating the application could not be approved in its present form and required additional information from AstraZeneca.

Q: Is Saphnelo still available for patients?
A: Yes, the already-approved intravenous infusion form of Saphnelo remains commercially available for treating moderate to severe lupus.

Source: Investing.com