Date: 2017-07-20
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Actemra®/RoActemra®
Compound: tocilizumab
Therapeutic area: Autoimmune diseases
Action mechanism:
- monoclonal antibody. Actemra® is a humanized monoclonal antibody against the IL6 receptor. It works by inhibiting biological activity of IL-6 through competitively blocking the binding of IL-6 to its receptor.
Company: Roche (Switzerland)
Disease: giant cell arteritis
Latest news:
- • On July 20, 2017, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Actemra®/RoActemra® (tocilizumab) for the treatment of giant cell arteritis .If approved, Actemra / RoActemra would be the first therapy for the treatment of this chronic autoimmune condition in Europe.
- • On May 22, 2017, the FDA has approved Actemra® subcutaneous injection for the treatment of giant cell arteritis. Actemra® is the first therapy approved by the FDA for the treatment of adult patients with this disease. This is the sixth FDA approval for Actemra® since the medicine was launched in 2010.
The approval is based on the positive outcome of the Phase III GiACTA study evaluating Actemra® in patients with giant cell arteritis. The results showed that Actemra®, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through 52 weeks (56 percent in the Actemra® weekly group and 53.1 percent in the Actemra® bi-weekly group) compared to placebo combined with a 26-week steroid taper (14 percent) and placebo combined with a 52-week steroid taper (17.6 percent).
- • On January 24, 2017, the FDA has accepted the company’s supplemental biologics license application (sBLA) for Actemra®/RoActemra® (tocilizumab) for the treatment of giant cell arteritis. The FDA also granted priority review designation for Actemra®/RoActemra® for this indication.
- • On October 5, 2016, the FDA has granted Breakthrough Therapy Designation status to Actemra/RoActemra® (tocilizumab) for giant cell arteritis. 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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-05-22
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
