GSK Gains FDA and CHMP Support for Nucala and Blenrep

Published 1 hours agoGSK

GSK Gains FDA and CHMP Support for Nucala and Blenrep

GlaxoSmithKline (GSK) has secured crucial regulatory approvals for two key treatments, marking a significant advancement for the pharmaceutical company. The U.S. Food and Drug Administration has approved GSK’s drug, Nucala (mepolizumab), for use in certain patients with chronic obstructive pulmonary disease (COPD), a major leap as Nucala was formerly approved only for asthma. With COPD affecting over 14 million Americans, this approval presents new possibilities in reducing exacerbations for patients when used with inhaled therapy. According to Reuters, this represents a 21% reduction in exacerbations over a span of 104 weeks compared to placebo treatments.

In tandem with the FDA's decision, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Blenrep (belantamab mafodotin) for treating relapsed or refractory multiple myeloma in adults who have undergone prior therapy. This antibody-drug conjugate targets the BCMA protein on cancer cells, offering improved survival rates and disease control over standard treatments as demonstrated in late-stage studies.

GSK's recent regulatory milestones underscore its strategic focus on expanding its portfolio in respiratory and oncology care, catering to critical medical needs. The approvals from both the FDA and CHMP highlight GSK's commitment to addressing significant health challenges, providing enhanced options for managing serious conditions like COPD and blood cancer.

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