The injected drug Actemra (tocilizumab) has previously been approved by the US Food and Drug Administration to treat rheumatoid arthritis in people who haven’t responded to or who cannot tolerated other approved rheumatoid arthritis medication, Health24 reported.
Actemra has now been approved by the US Food and Drug Administration to treat adults with giant cell arteritis, an inflammation of the blood vessels (vasculitis).
In a media release, the FDA said this form of vasculitis mostly involves blood vessels of the head. Traditional therapy includes large doses of anti-inflammatory drugs called corticosteroids.
To be used ‘with caution’
“We expedited the development and review of this application because [Actemra] fulfils a critical need for patients with this serious disease who had limited treatment options,” said Dr Badrul Chowdhury, director of the agency’s Division of Pulmonary, Allergy, and Rheumatology Products.
It is, however, unclear what the situation is in South Africa.
Actemra was evaluated in clinical studies involving 251 people with giant cell arteritis. The drug will carry a boxed label warning of the possibility of serious infections. For that reason, live vaccines should be avoided while taking the drug, the FDA said.
And Actemra should be used “with caution” among people at increased risk of gastrointestinal perforation or dangerous allergic-like hypersensitivity reactions, the agency added.