The stock price once fell nearly 2%! AstraZeneca(AZN.US) Lupus Self-Injectable Drug Application Rejected by the FDA

The U.S. Food and Drug Administration (FDA) recently rejected AstraZeneca’s (AZN.US) application for the approval of a self-injection formulation of its lupus treatment. However, the British pharmaceutical company stated that it is still in communication with regulators and is working to advance the approval process.

On Tuesday, AstraZeneca issued a statement saying that the company has submitted all relevant materials in accordance with the FDA’s complete response letter and is committed to “expediting the approval process.” Following this news, AstraZeneca’s shares in London fell by as much as 1.9% in early trading, nearly erasing its full-year gains.

The drug, called Saphnelo, currently has an approved intravenous formulation, which requires patients to visit a hospital or clinic for intravenous treatment every four weeks. The application AstraZeneca submitted is for a subcutaneous injection formulation. If approved, patients could administer the medication themselves on a weekly basis. Data compiled shows that analysts forecast the drug’s annual revenue could exceed $1.6 billion by 2031.

Saphnelo is used to treat systemic lupus erythematosus, an autoimmune disease where the immune system mistakenly attacks healthy tissues. AstraZeneca disclosed that over 3.4 million people worldwide are affected by this disease.

The European Union approved the subcutaneous formulation of Saphnelo in December last year. A late-stage clinical trial of the self-injection version of Saphnelo showed that, compared to placebo, the drug effectively reduces disease severity.

It is reported that the FDA is expected to make a decision on AstraZeneca’s supplemental application in the first half of this year. During this period, the intravenous formulation of the drug will continue to be available as normal.