Patients with the most common form of lupus have a new treatment option, an AstraZeneca drug, which is now the first new treatment for autoimmune diseases since the GlaxoSmithKline drug cleared regulatory barriers ten years ago therapy.
FDA approved AstraZeneca’s drug anifrolumab covers adults with moderate to severe systemic lupus erythematosus, who are also receiving standard treatment, including anti-inflammatory and immunosuppressive drugs. AstraZeneca will market its new drug under the name “Saphnelo.”
The cause of lupus is unclear, but inflammatory diseases affect women disproportionately. Compared with other ethnic groups, this situation is more common among African Americans, Hispanics, and Asians. The most common form of the disease is systemic lupus erythematosus, which affects organs throughout the body and accounts for approximately 70% of lupus cases. American Lupus FoundationCutaneous lupus is limited to the skin, while drug-induced lupus is caused by certain prescription drugs and disappears within a few months after stopping the use of the culprit drug.
Saphnelo is an antibody designed to bind to some type I interferon receptors. Doing so will prevent the biological activity of type I interferon, a chain of amino acids that plays a role in the development of lupus. The company said its drugs also cause receptor internalization, which reduces the level of cell surface receptors that can bind to type I interferons. The AstraZeneca drug is the first lupus treatment approved by the FDA to work in this way.
In 2011, the FDA approved GlaxoSmithKline’s Benlysta, An antibody that interferes with the way in which B cells (a type of immune cell) survive. GSK drugs do not directly block B cells, but instead block a protein that promotes their survival. GlaxoSmithKline reports that Benlysta’s 2020 sales are 719 million pounds (more than 605.7 million U.S. dollars). This total includes the hypodermic version, which has sales of 354 million pounds (approximately US$298.2 million).
The most common side effects reported in clinical trials that test Saphnelo include cold symptoms, upper respiratory tract infections, bronchitis, infusion-related reactions, shingles, and cough. The drug’s label warns of serious and sometimes fatal infections in patients treated with drugs that suppress the immune system, including Saphnelo. The label also warns that immunosuppressants can increase the risk of cancer, although the effect of AstraZeneca’s drugs on cancer is unclear.
Saphnelo is currently undergoing review by European and Japanese regulatory agencies. A Phase III study evaluating subcutaneous drugs has begun. AstraZeneca also plans to test the drug in an additional phase 3 study of lupus that affects the kidneys, skin and muscles.
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