Roche granted breakthrough therapy designation by FDA
pharmafile | October 5, 2016 | News story | Research and Development | Actemra, FDA, Giant Cell arteritis, Roche, breakthrough therapy
Roche has announced that the FDA has granted its Actembra drug breakthrough therapy designation for giant cell arteritis. The breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to ensure that patients are able to have access to drugs as quickly as possible.
Giant cell arteritis is a chronic and potentially life-threatening autoimmune condition. The disease is caused by inflammation of large and medium-sized arteries, most often in the head but also in the aorta and its branches. Treatment, to date, has been limited to high-dose steroids that essentially act as an ‘emergency’ treatment option to prevent potential damage, such as vision loss. However, this method of treatment does not always maintain long-term disease control and can have severe side effects.
In July of 2016, Roche published positive data relating to a Phase III trial evaluating the efficacy of Actemra. Results showed that Actemra, initially combined with a six month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six or 12 month steroid-only regimen in people with GCA. Further details upon the study are expected to be released at some point this year.
“The FDA Breakthrough Therapy designation for GCA underscores our continued commitment to explore Actemra/RoActemra in autoimmune diseases with significant unmet need,” said Sandra Horning, M.D., Chief Medical Officer and head of Global Product Development. “We are looking forward to working with the FDA in the hope of making Actemra/RoActemra available to people with GCA, a condition for which there has been no approved treatment in more than 50 years.”
Ben Hargreaves
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
