The FDA Approves The Subcutaneous (SC) Formulation Of Actemra From Roche Holdings (OTCMKTS: RHHBY)
The US Food and Drug Administration (FDA) has endorsed the subcutaneous (SC) formulation of Actemra (tocilizumab) from Roche Holdings (OTCMKTS: RHHBY). The endorsement means that the treatment can be used in treating active polyarticular juvenile idiopathic arthritis (pJIA). However, there is a catch because it can only be used in patients older than two years. The approval of the SC formulation was as a result of data collected from a Phase 1b JIGSAW-117 trial. The trial which took 52 weeks involved 52 patients aged 1–17 years and those living/suffering from PJIA.
Let us analyze the efficacy of Actemra SC among pediatric patients
Those enrolled in the study were required to have encountered a previous inadequate response or intolerance to methotrexate. This meant they had to be Actemra-naive or were receiving Actemra IV. Results from the 52weeks of its administration, which was based on a bodyweight-based dosing regimen outlined a consistent safety profile on Model-computed PK and PD parameters. Efficacy of 28.8% (15/52) ISRs was also noted. There was no pressure to withdraw patients from treatment thanks to the mild severity in all the SRs.
In addition, there was a decrease in neutrophil counts, which we below w 1 × 10 per L occurred in 15.4% of patients. The formulation has been approved in most countries to treat both polyarticular juvenile idiopathic arthritis (pJIA) and systemic juvenile idiopathic arthritis (sJIA) in children.
However, MD and the Chief Medical Officer Sandra Horning said, “Polyarticular juvenile idiopathic arthritis is a rare, often painful disease in children.” Horning acknowledges the approval citing that it will offer an alternative to a majority of children suffering from the debilitating disease.
Roche’s strategy in fitting the right treatment for every patient
The pharmaceutical has come a long way in being the world’s largest biotech company. It has combined its strengths and put on a brave face in advancing science to improve people’s lives. The company is working with all the relevant authorities has differentiated medicines in oncology, immunology, infectious diseases as well as diseases of the central nervous system.
Roche has found its way into the World Health Organization Model Lists of Essential Medicines as a result of developing thirty medicines. It has close to 94,000 employees globally and has gained the recognition as the Group Leader in sustainability within the Pharmaceuticals.