Localized obesity

The FDA adjusted the risk of the medicine after identifying 82 cases worldwide from 1996 to 2024. Image credit: Shutterstock / Jeppe Gustafsson. The US Food and Drug Administration (FDA) is adding the risk of anaphylaxis to a new boxed warning of glatiramer acetate, a medicine for multiple sclerosis (MS). The agency issued the warning about the rare but serious risk of allergic reaction to the medicine, known under the brand names Copaxone and Glatopa, via a drug safety communication on 22 January. The products already have warnings of immediate post-injection reaction, chest pain, localised fat loss, and immune response modification, as per the drugs’ labels. Teva Pharmaceutical’s Copaxone was approved by the FDA in 1996 to treat relapsing forms of MS, an autoimmune disorder that affects the central nervous system. Glatopa, a generic version of Teva’s product, was approved by the FDA this year and marketed by Sandoz . The drugs have demonstrated a 34% drop in the number of relapses compared to placebo. The FDA adjusted the risk of the medicine after identifying 82 cases worldwide across the last 28 years. The agency said that although rare compared to how often the medicine is used, the serious allergic reactions meant emergency room visits or hospitalisations were required in all patients in the dataset. A majority of the 82 patients experienced anaphylaxis within one hour of taking the medicine and six died. The FDA’s alert follows a similar notification from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, which outlined the risk of anaphylactic reactions. The UK regulator said that allergy-related events could occur shortly after administration or take months or years after treatment initiation. A multiple sclerosis patient from Castlebar in Ireland died shortly after administering herself with Copaxone in June 2024, according to local newspaper Mayo Live . A post-mortem concluded she died of anaphylactic shock and a ‘suspected adverse reaction report was submitted to Ireland’s Health Products Regulatory Authority (HPRA). Identifying anaphylaxis associated with glatiramer acetate can be challenging because its initial symptoms are similar to immediate post-injection reaction, a temporary and common side effect. The FDA recommended healthcare professionals to educate patients on the signs and symptoms of post-injection reactions and told patients to immediately stop taking glatiramer acetate in the event of breathing difficulties, face or throat swelling, or rash appearance. Neither Teva nor Sandoz has publicly commented about the new boxed warning. Teva faced difficulties with the European Commission with Copaxone in November 2024. The agency fined Teva €462.6m ($481m) after concluding that the company artificially extended the therapy’s patent protection and disseminated misleading information about rival products.

GAITHERSBURG, Md. and SUZHOU, China, May 30, 2022 /PRNewswire/ -- Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today the launch of a Phase I clinical trial of the Company's siRNA (small interfering RNA) drug candidate, STP705, in adults undergoing abdominoplasty for submental fat reduction. This study is the first application for Sirnaomics to apply an RNAi therapeutic candidate for medical cosmetology treatment. The global non-invasive fat reduction market size was valued at USD1.1 billion in 2021 and is anticipated to register a compound annual growth rate (CAGR) of 16.1% from 2022 to 2030, up to approximately USD4.0 billion (Grand View Research). Non-invasive fat reduction is a procedure that is done to decrease or eliminate stubborn fat pockets in specific areas of the body by using methods like cryolipolysis, radio frequency, and laser lipolysis. Non-invasive devices that are used in these procedures to permanently abolish fat cells are approved by the U.S. Food and Drug Administration (FDA) as their efficiency and safety have been tested and the results have been proven to show significant results. However, the market is currently dominated by devices that have mild therapeutic effects and require multiple treatment sessions. Sirnaomics will initially focus on the use of STP705 for submental fat reduction. The dose-ranging, randomized, double-blind, vehicle-controlled study will enroll 10 patients to evaluate the safety and tolerability of STP705, which will be delivered via subcutaneous injection. The primary endpoints are to assess injection comfort, characterize local and systemic safety, and evaluate histological changes of subcutaneous doses of STP705, and to compare the safety and tolerability of three different concentrations of STP705 to select dosages for future studies. "Submental fullness is a common condition that is resistant to diet and exercise and is influenced by multiple factors including aging and genetics," said Sirnaomics Executive Director and Chief Medical Officer Michael Molyneaux M.D. "Our goal in expanding our applications of STP705 with this study is to examine the safety and efficacy of this treatment in patients who are undergoing abdominoplasty. We hope to use the information from this study to expand into the treatment of submental fat reduction and other areas of non-invasive fat sculpting. This Phase I study will serve as a blueprint for future studies of STP705 in the medical aesthetics category." "The current devices and procedures for non-invasive fat reduction have mild therapeutic effects, and require multiple and sometimes challenging treatment sessions, which are costly for patients and don't always achieve the desired results," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Based on a discovery from our previous clinical study and a series of preclinical evaluations with animal models, we decided to expand STP705 therapeutic application into medical aesthetics with this Phase I study." About STP705 Sirnaomics' leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in five clinical trials for different indications: a Phase IIa for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), and a Phase I for liver cancer (basket). About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates in preclinical and clinical stages that focuses on the discovery and development of innovative drugs for indications with medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both China and the United States, and also the first company to achieve positive Phase IIa clinical outcomes in oncology for an RNAi therapeutics for its core product, STP705. Learn more at www.sirnaomics.com.