Novartis Gets CHMP Opinion for Label Expansion of Fabhalta

Core Viewpoint - Novartis has received a positive opinion from the CHMP for the label expansion of Fabhalta, an oral Factor B inhibitor, for treating adults with C3 glomerulopathy, a rare kidney disease with no current approved treatments [1][2]. Group 1: Fabhalta's Approval and Clinical Data - The European Commission is expected to make a final decision on Fabhalta's marketing authorization in two months [2]. - The CHMP's recommendation is based on data from the APPEAR-C3G study, which demonstrated a 35.1% reduction in proteinuria in patients treated with Fabhalta compared to placebo [2]. Group 2: Market Position and Financial Performance - If approved, Fabhalta will be the only drug targeting the underlying cause of C3G [3]. - Novartis shares have increased by 6% over the past year, outperforming the industry average of 1.3% [3]. Group 3: Sales and Future Prospects - Fabhalta generated $57 million in sales in Q4, driven by growth in PNH and IgA nephropathy treatments [4]. - The drug is under review in the U.S. for C3G, with the FDA granting Priority Review status [5]. Group 4: Pipeline and Strategic Acquisitions - Novartis reported better-than-expected Q4 2024 results, with net sales projected to grow in the mid to high single digits in 2025 [6]. - The company is focusing on label expansions and strategic acquisitions to enhance its pipeline, including the acquisition of Anthos Therapeutics for$925 million, with potential additional payments of up to $2.15 billion [8][9]. Group 5: Recent Acquisitions - In 2024, Novartis acquired MorphoSys AG, adding late-stage and early-stage candidates to its pipeline [10].