Exciting new drug breakthrough for Lupus patients!
Great news for Lupus patients as the USA Food and Drug Adminstration (FDA) approves a new drug to treat adult patients who have moderate to severe Lupus erythematosus (SLE), despite recieving standard treatment. The approval was based on efficacy and safety data from AstraZeneca's Saphnelo (anifrolumab) clincal development program. "In these trials, more patients treated with Saphnelo (anifrolumab) experienced a reduction in overall activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared with both groups receiving standard therapy." (Source: AstraZeneca website). Saphnelo is the first new drug approved for the treatment of Lupus (SLE) for more than a decade and the only second in 60 years.
With this annoucement, use of the drug is approved for use in the USA but not Australia. Approval for new drug use in Australia is handled by by Australia's regulatory body, the Therapeutic Goods Aministration (TGA),- Lupus Victoria understands the TGA is currently assessing the application and if approved, availability would thereafter depend on whether the Federal Health Minister approves the drug tp be placed on the Pharmaceutical Benefits Scheme (PBS). Lupus Victoria urges the TGA and PBS to consider the high unmet need of SLE patients in Australia, as non-approval of this drug would mean 2 out of 2 breakthrough lupus drugs available worldwide in the last decade are denied to Australian patients.
Professor Eric Morand, principal investigator in the global Saphnelo clincal development program, said, "The FDA approval of anifrolumab protentially allows thousands of lupus patents to benifit. Decreased disease activity, along with reduced steriod use, from the pillors of treatment goals in lupus, and anifrolumab has shown these effects." (Source: Lupus Reserah Alliance). He added, "I am so keen for this drug to be available to Australian lupus patients, as I think it has the potential to be truly a game changer".
Lupus Victoria is delighted that its funding of the Kim Jolly Lupus Research Fund has assisted Professor Eric Morand and his team to achieve this amazing breakthrough. Professor Eric Morand is Head of the School of Clinical Sciences at Monash Health, Monash University's largest clinical school, and a physician scientist. He specialises in research and clinical care of systemic lupus erythematosus, as well as complex rheumatic diseases and rheumatoid arthritis. He is founder of the Monash Lupus Clinic , Australia's largest research- grounded clinic for patients with SLE and is a founding member of the Australian Lupus Registry and Boonank.
3rd August 2021