GSK shares saw a 1% rise Monday morning as regulators from the US and China moved to review its innovative therapies aimed at treating lung disease and multiple myeloma. In the US, the Food and Drug Administration has accepted GSK's application to expand the use of its drug Nucala, known scientifically as mepolizumab.
This application seeks to introduce the drug as an add-on maintenance therapy for chronic obstructive pulmonary disease (COPD) patients exhibiting an eosinophilic phenotype. The Prescription Drug User Fee Act set the action date for GSK's application to May 7, 2025. The Nucala submission is backed by results from the Matinee trial, which involved 804 patients diagnosed with COPD.
The research demonstrated that the addition of mepolizumab to traditional inhaled maintenance therapy led to a decrease in moderate-to-severe exacerbations for those with an eosinophilic phenotype, thus fulfilling its primary endpoint. Currently, this monoclonal antibody is approved in the US for treating severe asthma in patients who are six years old and above, along with chronic rhinosinusitis with nasal polyps and various other respiratory disorders. In a parallel development in China, GSK's belantamab mafodotin, marketed under the brand name Blenrep, has received priority review status from the National Medical Products Administration.
This drug is aimed for use alongside bortezomib and dexamethasone in patients suffering from relapsed or refractory multiple myeloma. The combination had been granted breakthrough therapy designation back in September. This application is bolstered by interim results from the phase 3 Dreamm-7 trial, which indicated a statistically significant and clinically relevant enhancement in progression-free survival among trial participants.
This trial was multicentric and open-label, enrolling 494 participants. GSK's combinations of belantamab mafodotin have already been accepted for scrutiny in several other markets, including the US, EU, Japan, UK, Canada, and Switzerland. “Innovative options are crucial for multiple myeloma patients, especially during the first relapse.
The DREAMM-7 trial results indicate notable efficacy, including overall survival rates and may redefine the treatment landscape for these patients,” remarked Hesham Abdullah, GSK's Senior Vice President and Global Head of Oncology Research and Development..