The US Food and Drug Administration has approved Xeljanz (tofacitinib) a Janus kinase (JAK) inhibitor developed by Pfizer Inc for the treatment of rheumatoid arthritis. The approval represents a new treatment option in a field currently dominated by biologics.
After a trial delay that triggered a corporate restructuring, Pharming Group NV of the Netherlands has now reported positive clinical data for Ruconest, its lead drug for hereditary angioedema (HAE). A US regulatory filing is expected in the 2013 first half.
The Lancet has published two Phase 3 studies of the Sanofi SA multiple sclerosis drug, Lemtrada (alemtuzumab), which show that the antibody significantly reduced relapse rates of the disease compared with the standard of care – Rebif (interferon beta 1a).
The US Food and Drug Administration has approved a new drug to treat chronic myelogenous leukaemia – the second therapy to be approved for CML in about two months. The drug, Synribo (omacetaxine mepesuccinate), comes from Teva.
The European Medicines Agency has started an infringement procedure against Roche for alleged deficiencies in its medicine-safety reporting system. It is the first time the agency has started a procedure of this kind against a company.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a new diagnostic for patients who are being evaluated for Alzheimer’s disease – the first of its kind.
The US Food and Drug Administration has expanded the approved indication for an artificial heart valve manufactured by Edwards Lifesciences Corp to include patients with aortic valve stenosis who are eligible for surgery but at a high risk of complications.
The US Food and Drug Administration has approved ocriplasmin (Jetrea), the first pharmaceutical product for treating for symptomatic vitreomacular adhesion, which occurs when the vitreous gel of the eye fails to detach from the retina.
The US Food and Drug Administration has approved a new indication for Humira (adalimumab) to include the treatment of moderate-to-severe ulcerative colitis in adults. It is the seventh US approval for the drug which is marketed by Abbott Laboratories.
The US Food and Drug Administration has approved Stivarga (regorafenib), a multi-kinase inhibitor, to treat patients with metastatic colorectal cancer. Developed by Bayer AG, the drug was approved under the agency’s priority review procedure.