shutterstock_179291957

CHMP issues positive opinion for Orencia Rheumatoid Arthritis treatment

pharmafile | July 25, 2016 | News story | Manufacturing and Production, Sales and Marketing BMS, CHMP, Orencia, rheumatoid arthritis 

Bristol-Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) has released a positive opinion of Orencia (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate (MTX) in the treatment of adult patients suffering from highly active and progressive rheumatoid arthritis (RA) not previously treated with MTX.

The recommendation is now due to be reviewed by the European Commission, who will authorise the drug’s approval in the EU. If approved, Orencia will be the first EU-indicated biologic therapy to be specifically applicable to the treatment of MTX-naïve RA patients.

In clinical trials, the drug was found to perform with significant efficacy when used in conjunction with MTX as opposed to treatment using MTX alone for patients with moderate to severe RA, with significantly more patients achieving DAS28-defined remission after 12 months.

“This CHMP recommendation is particularly notable because it is the first time that MRI-detected structural and inflammatory measures of disease severity are cited as support for the proposed RA indication,” remarked Paul Emery, arthritis research UK professor of rheumatology and head of the academic division of musculoskeletal disease at the Leeds Institute of Molecular Medicine. “This is consistent with mounting evidence supporting a paradigm shift in how and when we initiate different forms of RA therapy, particularly for those patients with progressive disease accompanied by certain poor prognostic markers.”

Related Content

J&J gains positive CHMP opinion for Rybrevant for treatment of lung cancer

Janssen, a Johnson & Johnson (J&J) company, has announced that the Committee for Medicinal Products …

CHMP recommends Novo Nordisk’s Awiqli for diabetes treatment

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for …

louis-reed-pwckf7l4-no-unsplash_5

EMA validates two applications for datopotamab deruxtecan for cancer treatments

AstraZeneca has announced that the European Medicines Agency (EMA) has validated to marketing authorisation applications …

Latest content