Pharmaceutical giant GlaxoSmithKline (GSK) has won additional regulator approvals for its monoclonal antibody drug Nucala.
Originally given the FDA (Food & Drug Administration) thumbs-up as a treatment for patients with chronic rhinosinusitis (inflamation of the nasal cavity) with nasal polyps in July 2021, the new approvals expand the treatment’s use for diseases associated with elevated levels of eosinophils, a type of white blood cell which causes inflammation of the nasal passage.
The latest European Commission approvals means Nucala is now the only approved treatment in Europe for four eosinophils related diseases. It is already approved for use as an add-on treatment for patients aged six and over suffering from severe eosinophilic asthma.
The lives of patients suffering from eosinophils related diseases can be impacted by severe and life-threatening symptoms.
COVID-19 DRUG ORDER
Separately, it was reported yesterday the US Government had placed orders worth around $1 billion for GSK’s and US-listed Vir Biotechnology’s antibody-based Covid-19 drug sotrovimad, used for treating high risk patients with mild-to-moderate Covid-19.
Results of a late stage trial showed sotrovimad reduced the risk of hospitalisation and death by 85% in high risk patients. The drug was granted emergency use approval in the US on 26 May.
Supply is expected to begin mid-December and GSK said the US order brought the number of doses ordered globally to 750,000.
GSK’s shares traded 0.6% lower at £15.49.
