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Top news of the day from across the health care landscape.
Alnylam Pharmaceuticals has priced givosiran (Givlaari), a new treatment for acute hepatic porphyria, at $575,000 per year after receiving FDA approval on Wednesday, Reuters reported. According to the article, the injection, which is dosed based on patient weight, will be available after discounts at $442,000 per year. The company also said it reached a value-based agreement in principle with Harvard Pilgrim Healthcare to cover the drug and was in talks with other health insurers, the article reported.
A recent review of biologic use in children indicates the need for more data to demonstrate the safety and efficacy of these medications in this patient population, The Center for Biosimilars reported. According to the article, the review explored the evidence of monoclonal antibodies and fusion proteins in children with common chronic inflammatory diseases, including bronchial asthma, psoriasis, juvenile idiopathic arthritis, and chronic inflammatory bowel disease. The researchers found that most studies suffered from qualitative weakness that make it difficult to assess the safety and efficacy of these drugs, but concluded that biologics still represent an alternative therapeutic option for children in whom conventional immunomodulatory treatment is ineffective, the article reported.
New data from an ongoing real-world study showed that empagliflozin was linked to less hospitalization for heart failure (HF) than 2 other drug classes for type 2 diabetes, The American Journal of Managed Care reported. According to the article, the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) study, which will examine 5 years of real-world data, is comparing data on empagliflozin with that for dipeptidyl peptidase 4 (DPP-4) inhibitors in 190,000 adults with type 2 diabetes, with and without cardiovascular disease. Overall, the main 3-year analysis showed that empagliflozin was associated with a 41% risk reduction in hospitalization for HF compared with DPP-4 inhibitors and 17% compared with GLP-1 receptor agonists, the article reported.
FDA Approves Eladocagene Exuparvovec-Tneq for Treatment of AADC Deficiency