Date: 2017-07-25
Type of information: Submission of a Market Application in the US
Product name: Cimzia®
Compound: certolizumab pegol
Therapeutic area: Autoimmune diseases - Dermatological diseases
Action mechanism:
- monoclonal antibody/TNF alpha inhibitor. Cimzia® is a Fc-free, pegylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
- In July 2014, UCB has granted Dermira an exclusive license to develop certolizumab pegol in psoriasis in the US, Canada and the European Union.
- Cimzia® is not currently approved for the treatment of psoriasis by any regulatory authority.
Company: UCB (Belgium) Dermira (USA - CA)
Disease: moderate to severe chronic plaque psoriasis
Latest news:
- • On July 25, 2017, UCB and Dermira announced the UCB submission of a supplemental Biologics License Application (sBLA) to the FDA for Cimzia® (certolizumab pegol). Separately, UCB also submitted a regulatory filing with the European Medicines Agency (EMA). Both regulatory filings seek to expand the approved indications for Cimzia® to include treatment of adult patients with moderate-to-severe chronic plaque psoriasis. An additional submission to expand the use of Cimzia® in this patient population is also planned with Health Canada.
- The Phase 3 Cimzia® clinical development program in psoriasis was led by Dermira, in collaboration with UCB as the regulatory sponsor.
The regulatory submissions are based on results from three Phase 3 clinical trials – CIMPASI-1, CIMPASI-2 and CIMPACT, which each evaluated the efficacy and safety of Cimzia® in adult patients with moderate-to-severe chronic plaque psoriasis. The co-primary endpoints evaluated in both CIMPASI-1 and CIMPASI-2 were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16. The primary endpoint in CIMPACT was the percentage of patients on CIMZIA achieving a PASI 75 response, compared with placebo, at week 12. Secondary endpoints of the CIMPACT trial included a comparison of the efficacy of Cimzia® to Enbrel® (etanercept) as measured by PASI 75 response at week 12 and the percentage of patients who achieved at least a two-point improvement to a final score representing clear or almost clear skin on the five-point PGA scale, at week 12.
- The three Phase 3 trials enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products. In CIMPASI-1 and CIMPASI-2, patients were randomized to one of three dosing arms—400 mg every two weeks, 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks, or placebo every two weeks. In CIMPACT, patients were randomized to one of four dosing arms—Cimzia® at 400 mg every two weeks, Cimzia® at 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks, Enbrel at 50 mg twice weekly, or placebo every two weeks. In all three trials, Cimzia® demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at all treatment doses.
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:
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
