AveXis, Novartis’ gene therapy division, announced that it has been given European approval for Zolgensma, (onasemnogene abeparvovec), the only gene therapy for spinal muscular atrophy (SMA). Specifically, the European Commission has granted conditional approval for Zolgensma for the treatment of patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and a clinical
Novartis has announced they have received EC approval for Beovu, an injection for the treatment of wet age-related macular degeneration (AMD). Novartis also stated that the therapy is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid, which is a key marker of disease activity, compared to Bayer’s Eylea in the trial’s
Novartis unit Sandoz has gained approval from the FDA for its filgrastim biosimilar, Ziextenzo. Ziextenzo is a long-acting form of filgrastim approved to reduce the incidence of infection in cancer patients that are receiving chemotherapy. The Infections tend to be manifested by low white blood cell count and fever in patients with non-myeloid malignancies on
NICE have said in a recent statement that Novartis’ gene therapy Luxturna for a rare, inherited form of blindness should be available for routine NHS use in England and Wales. The one-off treatment, which was previously approvedin Europe last November, has been backed by the cost-effectiveness watchdog for use in children and adults living with vision
Novartis announces Ribociclib has been recommended by the NICE for use on the NHS in combination with fulvestrant, where exemestane plus everolimus is the most appropriate alternative, for treating women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer who have received prior endocrine therapy. Ribociclib in combination
NHS has three months to ensure that Novartis’ combination therapy dabrafenib/trametinib is routinely available to eligible skin cancer patients, after cost regulators published guidance backing funds for the treatment. NICE recommended the combination for use in patients with stage III BRAF V600 mutation-positive melanoma that has spread to lymph vessels, or lymph glands close to
Novartis is seeking approval from EU and US for use of experimental multiple sclerosis therapy, siponimod, to treat secondary progressive forms of MS. Secondary progressive multiple sclerosis (SPMS) is where the disease causes continuous worsening of neurological function over time, independent of relapses. Most people with relapsing remitting forms of MS will eventually go on
Gilenya, which the FDA first approved in adults back in 2010, has had its approval expanded to treat relapsing multiple sclerosis (MS) in children and adolescents over the age of 10 years. This is the first FDA approval of a drug to treat MS in paediatric patients. “For the first time, we have an FDA-approved
NICE have issued updated guidelines for the treatment of wet age-related macular degeneration, by continuing to back use of both Bayer’s Eylea and Novartis’ Lucentis. According to the guidelines issued by NICE, the intravitreal anti-vascular endothelial growth factor (VEGF) treatment should be recommended for late AMD (wet active) for eyes with visual acuity within a
Novartis’ Afinitor and Pfizer’s Sutent have gained backing from NICE as cost-effective treatment options for certain neuroendocrine tumours (NETs). The public body has published final guidelines recommending both drugs for ‘routine’ NHS commissioning when NETs of the pancreas cannot be operated on and have progressed.
