Roche’s Actemra granted Priority Review by FDA
pharmafile | January 24, 2017 | News story | Manufacturing and Production, Sales and Marketing | Actemra, FDA, Roche, priority review
Roche’s drug, Actemra (also known as RoActemra in Europe), has been granted priority review designation by the FDA for the treatment of giant cell arteritis (GCA).
The designation was granted on the back of positive Phase 3 trial results that saw patients suffering from GCA treated with Actemra, alongside a six-month steroid regimen, experience a ‘more effectively sustained remission’ in comparison with a six or 12 month steroid treatment alone.
The trial, named GIACTA, involved 251 patients across 14 countries, with the results examined after 52 weeks. The trial met both its primary and key secondary endpoints.
“This positive outcome in GCA, a condition for which there have been no new treatments in more than 50 years, demonstrates Genentech’s commitment to helping patients with unmet needs,” said Sandra Horning, chief medical officer and head of Global Product Development. “We are pleased by the FDA’s decision to classify their review of the sBLA as priority. We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible.”
Actemra is already an important drug within Roche’s drug cabinet, being its fifth-largest selling drug and bringing in profits of $833 million in the first half of 2016 alone. As mentioned by Horning in Roche’s statement, the outcome of the review could lead to a new treatment for GCA and expand Actemra’s label – further boosting the sales of the drug. GCA currently effects 200 people per 100,000 in those over the age of 50 and, as it would become the newest available treatment, would therefore see its sales increase by a significant number.
Ben Hargreaves
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