GSK Receives European Approval for Three Additional Indications of Nucala
GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.
GlaxoSmithKline (GSK) has been granted approval by the European Commission (EC) for its monoclonal antibody therapy, Nucala (mepolizumab), which targets interleukin-5 (IL-5) as a treatment for three additional eosinophil-driven diseases.
According to a Nov. 17, 2021 press release, the approval follows on from the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) and means that Nucala can be used as an add on treatment in hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and chronic rhinosinusitis with nasal polyps. The commission’s decision has been based on data from pivotal trials that have investigated the role of targeted IL-5 inhibition with mepolizumab in the three aforementioned eosinophil-driven diseases.
“With millions of patients across Europe affected by eosinophil-driven diseases, we recognize the urgency in delivering the first approved targeted treatment for use in four of these conditions,” said Hal Barron, chief scientific officer and president R&D, GSK, in the press release. “Today’s approvals reinforce the important role treatments such as mepolizumab can play in helping to improve the lives of patients with these debilitating diseases.”
“The lives of patients affected by an eosinophil-driven disease are often impacted by what can be severe or life-threatening symptoms. They may rely on both intermittent or continuous oral steroids to manage their condition or be left feeling they have no option but to endure ongoing symptoms and possible flare-ups,” added Tonya Winders, CEO & president, Allergy and Asthma Network and president of Global Allergy and Airways Patient Platform, in the press release. “The availability of mepolizumab, a targeted biologic therapy, provides patients and their healthcare professionals with a new option in their armamentarium to treat hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and chronic rhinosinusitis with nasal polyps.”
Source: GSK
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
