The European Medicines Agency (EMA) has approved a label extension for UCB’s Cimzia (certolizumab pegol) for adult patients with axial spondyloarthritis (axSpA) at a reduced maintenance dose.
This means that axSpA patients can now reduce the dose to 200mg every four weeks once sustained remission is achieved after one year of treatment with Cimzia taken every two weeks, or 400mg every four weeks.
According to UCB, this label extension makes Cimzia the only biologic in Europe with a dose reduction option in its label for axSpA patients.The approval was based on data from the Phase IIIb C-OPTIMISE trial of Cimzia in adults with early active axSpA. At week 48 of the induction period, 43.9% of patients achieved sustained remission and at week 96, 84%, 79% and 20% of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, remained flare-free.
“AxSpA patients typically experience symptom onset in their mid-twenties and may therefore be concerned about lifelong continuation of therapy,” said Robert Landewé, Amsterdam Rheumatology & Clinical Immunology Center, and lead author of the C-OPTIMISE study.
“The CIMZIA label extension now offers healthcare providers a validated dose reduction strategy that can meet the needs of patients. Furthermore, the option to reduce the maintenance dose may provide cost reductions, benefiting the wider healthcare system,” he added.
Maintenance dose reduction supports the long-term management of patients with axSpA when sustained disease remission has been achieved.
The Cimzia label extension addresses an unmet medical need by providing the first validated dose reduction for patients across the axSpA spectrum, said UCB.
By: Lucy Parsons
Source: Pharma Times
Airnov provides critical healthcare industries with high-quality, controlled atmosphere packaging, to protect their products from moisture and oxygen. The business has manufacturing facilities in the USA, France, China and India and employs around 700 people.
Takeda of Japan has partnered with Hong Kong-based Hutchmed, gaining the commercial rights to colorectal cancer drug fruquintinib outside of China for $400 million up front, plus $730 million in potential milestone payments. Takeda also will help develop fruquintinib, which can be applied to subtypes of refractory metastatic colorectal cancer, regardless of biomarker status, the companies said.
On April 3, Scangos, who’s been chief executive officer at Vir since the start of 2017, will hand over the reins to Marianne De Backer, Ph.D. De Backer comes over from Bayer, where she currently heads up pharmaceutical strategy, business development and licensing. Alongside her CEO appointment, De Backer is set to join Vir’s board of directors, the company said Wednesday.