The US Food and Drug Administration has approved a new indication for the cystic fibrosis medicine Kalydeco (ivacaftor) which extends coverage to patients whose disease is caused by the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The US Food and Drug Administration has approved Saxenda, a glucagon-like peptide-1 receptor agonist developed by Novo Nordisk A/S for the treatment of weight management in addition to a reduced-calorie diet and exercise.
Seven experimental medicines intended to treat patients infected by the Ebola virus are not yet ready for authorisation, largely because there is insufficient information about their safety and effectiveness, according to the European Medicines Agency.
The Food and Drug Administration has given its first approval to a single-agent immunotherapy for cancer – Amgen Inc’s Blincyto (blinatumomab) for the treatment of refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
A kinase inhibitor which is already authorised for myelofibrosis has now been approved by the Food and Drug Administration for polycythemia vera, another bone marrow disorder. The drug, Jakafi (ruxolitinib), was developed by Incyte Pharmaceuticals Inc and Novartis.
After issuing a complete response letter in late 2013, the Food and Drug Administration has now approved Lemtrada (alemtuzumab) for patients with relapsing multiple sclerosis. This follows a review of efficacy data from two Phase 3 trials.
Olaparib, a drug with an unusual clinical history, has been given a positive scientific review by the European Medicines Agency paving the way for its use as a treatment for women with a subtype of ovarian cancer.
The European Medicines Agency said that it now has procedures in place to review data on candidate vaccines or therapies aimed at protecting or treating patients infected with the Ebola virus with a view to making these medicines available as quickly as possible.
The US Food and Drug Administration has approved the first combination pill to treat chronic hepatitis C virus genotype 1 infection. Harvoni (ledipasvir and sofosbuvir) is also the first treatment that doesn’t require co-administration with interferon or ribaviron.
The European Medicines Agency’s Committee for Advanced Therapies (CAT) is recommending that the marketing authorisation for the cartilage implant Maci be suspended because the developer, Genzyme (Sanofi SA), has closed the product’s EU manufacturing site.