GSK’s biologic Nucala is the first therapy specifically approved in the US to treat a rare disease called eosinophilic granulomatosis with polyangiitis (EPGA). EGPA is an autoimmune disease that causes vasculitis, which is an inflammation in the wall of blood vessels of the body. The disease is characterised by asthma, high levels of eosinophils, and
NICE have recommended Roche’s Tecentriq for use within the Cancer Drugs Fund (CDF) to treat advanced urothelial cancer in specific circumstances. In final draft guidelines issued by the public body, Tecentriq is being backed for use in patients whose urothelial cancer has not yet been treated and who aren’t suitable for cisplatin-based chemotherapy. At first
Merck Sharp & Dohme’s Keytruda has received approval in Europe for metastatic urothelial carcinoma allowing it to catch up with its immunotherapy rivals. Although, while BMS’ Opdivo and Roche’s Tecentriq beat MSD to approval in Europe earlier this year, Keytruda is the first treatment to show superior overall survival when compared to using chemotherapy in
Soliris approved by European Commission to treat adults with gMG, will be picked up by Germany first
Alexion has won new European indication for its ultra-orphan drug, Soliris, and has picked Germany to be its first launch market. Soliris received the green light from the European Commission to treat adults with generalised myasthenia gravis (gMG), who are anti-acetylcholine receptor antibody-positive. The extended indication for the first-in-class inhibitor was based on the back
GlaxoSmithKline and Innoviva have applied in Europe to market Relvar Ellipta for extended use in patients with asthma who are already adequately controlled on inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy. The treatment, comprised of the ICS fluticasone furoate (FF) and the LABA vilanterol (VI), is currently indicated in Europe for the regular treatment of patients
Eli Lilly’s experimental breast cancer drug, abemaciclib, has been granted a priority review by US regulators for two indications, and is now on track to be filed in Europe later in 2017.
National Institute for Health and Care Excellence in England and Wales are backing routine use of Allergan’s Ozurdex and AbbVie’s Humira as treatment for non-infectious posterior uveitis, which is a form of preventable vision loss. The cost regulators published their Final Appraisal Determination recommending the drugs as cost and clinically-effective treatment options for those with
Eleven new medicines have been put forward for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use, including new options for a rare eye disease, schizophrenia and cartilage defects. Oxervate won backing as a treatment for moderate or severe neurotrophic keratitis, a rare eye disease that can lead to loss of
Janssen announces that it has secured recommendation from NICE for Stelara, first of its kind, to treat moderately to severely active Crohn’s disease in adults who have previously proved unresponsive to conventional therapy or a TNFα inhibitor.
Patients with plaque psoriasis will be able to gain routine access to Eli Lilly’s Taltz on the NHS within the next three months if they meet certain eligibility criteria. NICE, has published final guidelines backing use of the drug but only if the disease is severe, as defined by a total Psoriasis Area and Severity