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Date: 2015-01-21

Type of information: Granting of a Market Authorisation in the US

Product name: Cosentyx® (AIN457)

Compound: secukinumab

Therapeutic area: Autoimmune diseases - Dermatological diseases

Action mechanism:

  • monoclonal antibody. Secukinumab (AIN457) is a fully human monoclonal antibody being investigated for diseases that affect the immune system. Secukinumab stops a protein called interleukin-17A (IL-17A) from its involvement in the development of psoriasis. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies.

Company: Novartis (Switzerland)

Disease: moderate-to-severe plaque psoriasis

Latest news:

  • • On January 21, 2015, the FDA approved Cosentyx®(secukinumab) to treat adults with moderate-to-severe plaque psoriasis. Cosentyx® is administered as an injection under the skin. It is intended for patients who are candidates for systemic therapy, phototherapy (ultraviolet light treatment) or a combination of both. Cosentyx®’s safety and effectiveness were established in four clinical trials with a total of 2,403 participants with plaque psoriasis who were candidates for phototherapy or systemic therapy.
  • Cosentyx® is being approved with a Medication Guide to inform patients that, because Cosentyx® is a medicine that affects the immune system, patients may have a greater risk of getting an infection. Serious allergic reactions have been reported with the use of Cosentyx. Caution should be exercised when considering the use of Cosentyx® in patients with a chronic infection or history of recurrent infection, and in patients with active Crohn’s Disease. The most common side effects include diarrhea and upper respiratory infections.
  • • On January 19, 2015, Novartis announced that the European Commission (EC) has approved Cosentyx® (secukinumab) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. Cosentyx® (at a dose of 300 mg) is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe and this approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients. Currently, all biologic treatments for psoriasis, including anti-tumor necrosis factor therapies (anti-TNFs) and Stelara®** (ustekinumab) are recommended for second-line systemic therapy in Europe. The key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90), during the first 16 weeks of treatment and importantly, this was maintained with continued treatment in the majority of patients up to Week 52[6]. Data from the Cosentyx clinical trial program also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life.
  • The EU approval follows the recent results of the Phase IIIb CLEAR study, which showed that Cosentyx was superior to Stelara®** in clearing skin of patients living with moderate-to-severe plaque psoriasis. The CLEAR study was the second head-to-head study for Cosentyx. Cosentyx also showed superiority to Enbrel®*** (etanercept) in clearing skin in the FIXTURE study[6]. In the Phase III clinical program the overall safety profile of Cosentyx® was favorable, with minimal differences seen between etanercept and ustekinumab in head-to-head comparison. In addition to the EU, Cosentyx has been approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). The FDA decision in moderate-to-severe plaque psoriasis is anticipated early in 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.
  • • On December 26, 2014, Novartis announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Cosentyx® (secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic arthritis (PsA) in adults who are not adequately responding to systemic therapies (except for biologics). This approval marks the first country approval for Cosentyx® in the world and makes it the first interleukin-17A (IL-17A) inhibitor to receive regulatory approval in either of these indications in Japan. In psoriasis clinical trials, 70% of patients achieved clear or almost clear skin within the first 16 weeks of treatment with Cosentyx 300 mg (p<0.0001), which was maintained in the majority of patients up to Week 52 (with continued treatment)[1]. In the PsA trials, Cosentyx demonstrated significant and sustained efficacy versus placebo in improving signs and symptoms of PsA, as measured by a 20% reduction in the American College of Rheumatology response criteria (ACR 20), which is a standard criteria to assess the effectiveness of arthritis treatments. Between 50% to 54% of Cosentyx patients achieved at least ACR 20 in two pivotal studies, FUTURE 1 (150 mg; p<0.0001) and FUTURE 2 (150 and 300 mg; p<0.0001). This approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis[1-3],[13] and supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA[4],[5]. In all studies, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events (AEs) between Cosentyx treatment arms (300 mg and 150 mg). The positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending Cosentyx as a first-line treatment of moderate-to-severe psoriasis patients in Europe was obtained in November 2014. FDA approval in the same indication is anticipated in early 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA. Phase III development for psoriatic arthritis and ankylosing spondylitis is also underway; global regulatory applications for Cosentyx® in these arthritic conditions are planned for 2015.
  • • On 20 November 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Cosentyx® powder for solution for injection, solution for injection in pre-filled pen, solution for injection  in pre-filled syringe intended for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The benefits with Cosentyx® are its ability to show superiority to placebo with respect to the co-primary  endpoints Psoriasis Area and Severity Index score (PASI) 75 and Investigator’s Global Assessment (IGA mod 2011) 0/1 response at Week 12. In a pooled analysis, PASI 90, PASI 100 and IGA 0/1 response rates indicating nearly complete/complete clearance were also statistically significantly better with Cosentyx® compared to placebo. Cosentyx® was statistically significantly superior to etanercept at Week 12 in achieving PASI 75 and IGA 0/1 response. Cosentyx® was efficacious in systemic treatment naive, biologic-naive, biologic/anti-tumour necrosis factor (TNF)-exposed and biologic/anti-TNF-failure patients. Improvements in PASI 75 in patients with concurrent psoriatic arthritis at baseline were similar to those in the overall plaque psoriasis population. The most frequently reported adverse drug reactions were upper respiratory tract infections (most frequently nasopharyngitis, rhinitis). Most of the reactions were mild or moderate in severity.
  • • On October 20, 2014, Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the FDA voted unanimously to support the approval of AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). The DODAC based its recommendation on the safety and efficacy outcomes from 10 psoriasis Phase II/III clinical studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis. The Phase III clinical program for secukinumab included four placebo-controlled pivotal studies which examined secukinumab 300 mg and 150 mg in patients with moderate-to-severe plaque psoriasis. In these studies, secukinumab met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator\'s Global Assessment modified 2011 (IGA mod 2011) 0/1 responses, showing significant skin clearance at Week 12. In addition, a majority of secukinumab-treated patients who achieved PASI 75 response and IGA mod 2011 0/1 at Week 12 maintained the response at Week 52 with continued treatment. PASI measures the redness, scaling and thickness of psoriatic plaques, and the extent of involvement in each region of the body. Treatment efficacy is assessed by the reduction of the score from baseline (i.e., a 75% reduction is known as PASI 75 and a 90% reduction is known as PASI 90). PASI 90 is a higher standard of skin clearance compared to PASI 75.
  • Currently available data showed no major safety issues. In the pooled analysis of the placebo-controlled period of the pivotal Phase III studies, the incidence of serious adverse events (SAEs) was low and comparable for both doses of secukinumab and placebo (2.0% for both 300 mg and 150 mg vs. 1.7% for placebo). Commonly reported adverse events (AEs) observed with secukinumab were nasopharyngitis, headache, diarrhea, pruritus (itching), and upper respiratory infection. Novartis submitted a Biologics License Application (BLA) for secukinumab to the FDA in October 2013 and the FDA action date is expected in early 2015. Additionally, submissions have been made with regulatory authorities in the EU with an expected decision anticipated in late 2014 or early 2015. According to an analysis of surveys conducted of 5,600 patients by the National Psoriasis Foundation (NPF) between 2003 and 2011, 52% of patients with mild, moderate and severe psoriasis were dissatisfied with their disease management. Of the patients surveyed, some were receiving no treatment (9.4-49.2%) or were undertreated (10.2-55.5%).

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: 2015-01-21

UE authorization: 2015-01-15

Favourable opinion UE: 2014-11-20

Favourable opinion USA: 2014-10-20

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

  • • On July 6, 2017,  Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx® (secukinumab). The label update includes 52 week data from the CLEAR study demonstrating the long-term superiority of Cosentyx® versus Stelara® (ustekinumab) in psoriasis. The updated label also includes use of Cosentyx to treat moderate-to-severe scalp psoriasis.
  • The addition of the CLEAR study data in the European product label reflects the benefit of Cosentyx® for people living with this chronic and often distressing condition. The 52 week data show that Cosentyx® is superior to Stelara® in delivering long-lasting clear or almost clear skin over one year of treatment in adults with moderate-to-severe psoriasis. Cosentyx® remained consistently superior to Stelara® in achieving and sustaining a PASI 90 response (76% versus 61%) and significantly better in achieving a PASI 100 (clear skin) response (46% versus 36%) at Week 52 (Blauvelt A et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. Journal of the American Academy of Dermatology.2017;76:60-69). The updated label for Cosentyx on scalp psoriasis is based on results from the 24 week study of moderate-to-severe scalp psoriasis where Cosentyx demonstrated superior efficacy compared to placebo. Psoriasis Scalp Severity Index (PSSI) 90 responses were achieved by a significantly greater percentage of patients receiving Cosentyx 300 mg (53%) than placebo (2%) at Week 12 (P<0.001) (Bagel J et al. Secukinumab is Efficacious in Clearing Moderate-to-Severe Scalp Psoriasis: 12 Week Results of a Randomized Phase IIIb Study. Publication. Presented as an abstract at the 25th European Academy of Dermatology and Venerology. Vienna, Austria. 1st October 2016).

Is general: Yes