Core Insights - Novartis announced that the FDA has approved the expanded indication for its siRNA therapy Leqvio (inclisiran), allowing it to be used as a monotherapy alongside diet and exercise to lower LDL-C levels in adults with hypercholesterolemia [1][2] - The FDA requested the label update based on positive data from the PCSK9-targeting therapy, removing the requirement for Leqvio to be used in conjunction with statins [1] - The label update also specifies the term "hypercholesterolemia" instead of "primary hyperlipidemia," emphasizing Leqvio's role in lowering LDL-C levels more accurately [1] Company Insights - Leqvio is a "first-in-class" siRNA therapy targeting PCSK9 mRNA, initially approved by the FDA in December 2021 as an adjunct to diet and statin therapy for adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) patients [2] - The mechanism of action involves reducing PCSK9 protein levels, which allows more LDL receptors to return to the liver cell surface, enhancing the clearance of LDL from the bloodstream [2] - Leqvio is noted as the first siRNA therapy capable of lowering LDL-C levels [2]

Core Insights - AbbVie has received FDA accelerated approval for its antibody-drug conjugate, telisotuzumab vedotin (Emrelis), for treating certain patients with non-small cell lung cancer (NSCLC) [1][2] - Emrelis is the first FDA-approved therapy for adult patients with locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression who have received prior systemic therapy [2] - The approval is based on data from the phase II LUMINOSITY study, which demonstrated a 35% overall response rate in patients with high c-Met protein overexpression [5] Company Developments - Emrelis marks a significant milestone for AbbVie as it is the company's first internally developed solid tumor drug and its first solid tumor therapy approved for lung cancer [4] - AbbVie has expanded its oncology portfolio to five therapies, including Imbruvica, Venclexta, Epkinly, Elahere, and Emrelis [8] - The company is also developing another c-Met targeting ADC, Temab-A, for metastatic colorectal cancer and gastroesophageal cancer [10] Pipeline and Collaborations - AbbVie is conducting a phase III confirmatory study called TeliMET NSCLC-01 to convert the accelerated approval of Emrelis into a full approval [5] - The company has entered into a collaboration with ADARx Pharmaceuticals to develop small interfering RNA (siRNA) therapeutics across multiple disease areas [11] - AbbVie will make an upfront payment of $335 million to ADARx, with potential milestone payments reaching several billion dollars [13]