Roche to file Actemra in inflamed artery disease
Roche/Genentech’s Actemra could have a new use soon, after a successful phase 3 trial in the inflamed artery disease, giant cell arteritis.
The Switzerland-headquartered company plans to file results of the study with regulators including the FDA by the end of this year.
The FDA has granted the drug Breakthrough Therapy designation, a status reserved for medicines to treat serious diseases allowing for faster development and review.
The GiACTA study met its primary demonstrating Actemra (tocilizumab) – initially in combination with a six-month steroid taper – enabling more patients to achieve sustained disease remission.
It also reduced steroid exposure compared with steroids alone, Roche noted.
No new safety signals were observed and these results are consistent with Actemra’s safety profile in rheumatoid arthritis.
An ongoing 104-week open label extension study is ongoing, and will provide data Actemra’s long-term safety and maintenance of efficacy beyond a year, as well as any potential long-term steroid sparing effects.
In Giant cell arteritis (GCA), medium and large arteries, usually in the head and neck, become inflamed.
GCA, which occurs in 200 per 100,000 people in the US over the age of 50, is difficult to diagnose and is two to three times more likely to affect women than men.
Symptoms include headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke.
Treatment has been limited to high-dose steroids that play a role as an effective emergency treatment option to prevent damage such as vision loss.
But they do not always maintain long-term disease control, Roche noted.
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