Date: 2018-05-22
Type of information: Granting of a Market Authorisation in the EU
Product name: Taltz®
Compound: ixekizumab
Therapeutic area: Autoimmune diseases - Dermatological diseases
Action mechanism:
Company: Eli Lilly (USA -IN)
Disease: moderate-to-severe plaque psoriasis
Latest news:
In these studies, the co-primary efficacy endpoints at 12 weeks were a 75 percent improvement in the composite Psoriasis Area Severity Index (PASI) score and static Physician's Global Assessment (sPGA) 0 or 1 and at least a 2-point improvement from baseline. In all three studies, at 12 weeks, 87 to 90 percent of patients treated with Taltz® saw a significant improvement of their psoriasis plaques (PASI 75). In addition, 81 to 83 percent of patients treated with Taltz® achieved sPGA 0 or 1. The majority of patients treated with Taltz®, 68 to 71 percent, achieved virtually clear skin (PASI 90) and 35 to 42 percent of patients saw complete resolution of their psoriasis plaques (PASI 100, sPGA 0). Among those patients treated with placebo, 7 percent or fewer achieved PASI 75, 7 percent or fewer achieved sPGA 0 or 1, 3 percent or fewer achieved PASI 90 and 1 percent or fewer achieved PASI 100 and sPGA 0.
In UNCOVER-1 and UNCOVER-2, of patients who responded to Taltz® (sPGA 0 or 1 and at least a 2-point improvement from baseline) at 12 weeks, 75 percent consistently maintained that response at the 60-week endpoint.
Taltz® was also statistically superior to etanercept at all skin clearance levels, including PASI 75 and sPGA 0 or 1 at 12 weeks. In an integrated analysis of the U.S. sites in the two active comparator studies—UNCOVER-2 and UNCOVER-3—the respective response rates for Taltz® vs. U.S.-approved etanercept were 87 percent vs. 41 percent for PASI 75 and 73 percent vs. 27 percent for sPGA 0 or 1.
Information regarding the safety of Taltz is drawn from a database of 4,204 patients with moderate-to-severe plaque psoriasis who volunteered in both controlled and uncontrolled clinical trials. Taltz ® may increase the risk of infection. Patients treated with Taltz had a higher rate of infections than patients treated with placebo (27 percent vs. 23 percent). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Taltz compared to placebo. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.
Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations. See Important Safety Information below.
In UNCOVER-2 and UNCOVER-3, the rate of serious adverse events during the controlled induction period (weeks 0-12) was 0.7 percent for U.S.-approved etanercept and 2 percent for Taltz, and the rate of discontinuation from adverse events was 0.7 percent for U.S.-approved etanercept and 2 percent for Taltz. The incidence of infections was 18 percent for U.S.-approved etanercept and 26 percent for Taltz. The rate of serious infections was 0.3 percent for both U.S.-approved etanercept and Taltz. Taltz® will be available in the U.S. beginning in the second quarter of 2016.
* On February 25, 2016, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive
opinion, recommending the granting of a marketing authorisation for Taltz® (ixekizumab) intended for the treatment of plaque psoriasis. Taltz® will be available as a 80 mg solution for injection. The benefits with Taltz® are its statistically significant and clinically relevant effects compared to placebo or etanercept in terms of ‘Psoriasis Area and Severity Index’ (PASI) score 75 and ‘static Physician Global Assessment of 0 or 1 (sPGA (0/1)) at week 12. PASI 90, PASI 100 and sPGA 0 response rates indicating nearly complete/complete clearance were also statistically significantly better with Taltz® compared toplacebo or etanercept. The most frequently reported adverse drug reactions were upper respiratory tract infections. Most of the reactions were mild or moderate in severity. The full indication is: "Taltz® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy". It is proposed that Taltz® is prescribed by physicians experienced in the treatment and diagnosis of psoriasis.
The CHMP positive opinion for ixekizumab was based on findings from the Phase 3 studies UNCOVER-1, UNCOVER-2 and UNCOVER-3 which demonstrated the safety and efficacy of ixekizumab in more than 3,800 patients in 21 countries with moderate-to-severe plaque psoriasis. All three studies evaluated the safety and efficacy of ixekizumab (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.
In these studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index (PASI) 75 and static Physician's Global Assessment (sPGA) 0 or 1.1 PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a required measure the FDA uses to evaluate effectiveness.
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: 2016-03-22
UE authorization: 2016-04-25
Favourable opinion UE: 2016-02-25
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
