The United States Food and Drug Administration has approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a healthcare professional.
“This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS,” said Billy Dunn, director of the Division of Neurology Products in Center for Drug Evaluation and Research.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women. The FDA granted approval of Ocrevus to Genentech.
Move to halve drug-related harm The World Health Organsiation has launched a global initiative to reduce severe, avoidable medication-associated harm in all countries by 50 per cent over the next five years.
The Global Patient Safety Challenge on Medication Safety aims to address the weaknesses in health systems that lead to medication errors and the severe harm that results. It lays out ways to improve the way medicines are prescribed, distributed and consumed, and increase awareness among patients about the risks associated with the improper use of medication.
Globally, the cost associated with medication errors has been estimated at $42 billion annually or almost 1 per cent of total global health expenditure.
IN THE PIPELINE
Medicines cleared for approval The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended six medicines for approval, including three with orphan designations: Refixia (nonacog beta pegol) for the treatment for adults with haemophilia B; Elmiron (pentosan polysulfate sodium) for treatment of bladder pain syndrome; and Dinutuximab beta Apeiron (dinutuximab beta) for treatment of neuroblastoma.