In the world of drug packaging, a vial is a vial, the product the product, and never the twain shall meet. When those standards start to slip, recalls are sure to follow.
GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has accepted for review a new drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA). If approved, Nucala would be the first targeted anti-Interleukin-5 (IL-5) treatment in China for adult and adolescent patients with this condition.
GlaxoSmithKline's Generic Nucala (Mepolizumab) Receives Approval in the U.S.
GlaxoSmithKline (GSK) plc announced that the European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three additional eosinophil-driven diseases. This authorisation follows positive opinions recommended by the Committee for Medicinal Products for Human Use and authorises mepolizumab for use as an add on treatment in hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP).
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended nine medicines including Biogen’s Vumerity (diroximel fumarate) and Roche’s Gavreto (pralsetinib) for approval.
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval for GlaxoSmithKline’s Nucala (mepolizumab) in three additional eosinophil-driven diseases.
GlaxoSmithKline (GSK) plc announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three eosinophil-driven diseases; hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP). The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval decision by the European Commission.
If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases
Mississauga, ON – NUCALA (mepolizumab) is now approved in Canada as an add-on to standard therapy for the treatment of adults with hypereosinophilic syndrome (HES) for ?6 months without an identifiable non-hematologic secondary cause.
Glaxosmithkline Biological Mepolizumab Receives Approval in US