EU Clears Brodalumab (Kyntheum) for Plaque Psoriasis

Megan Brooks

July 21, 2017

Brodalumab (Kyntheum, LEO Pharma, A/S) has been cleared in the European Union for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, AstraZeneca and MedImmune announced July 20 in a news release.

Brodalumab selectively inhibits interleukin-17 receptor A, thereby blocking the inflammatory response involved in plaque psoriasis.

EU clearance of the drug follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use on May 19. Brodalumab is already approved in the United States under the brand name Siliq.

Brodalumab was assessed in three randomized controlled clinical trials (AMAGINE 1-3) that involved more than 4300 patients.

As reported previously by Medscape Medical News, in AMAGINE-2 and AMAGINE-3, more patients treated with brodalumab than ustekinumab (Stelara, Janssen) achieved a Psoriasis Area Severity Index [PASI] response rate of 100 at 12 weeks (44% vs 22% in AMAGINE-2 and 37% vs 19% in AMAGINE-3; both P < .001).

In AMAGINE-1, 83.3% of patients on brodalumab 210 mg achieved PASI 75 compared to 2.7% of patients treated with placebo at 12 weeks (P < .001), and 75.7% of patients achieved a static Physician's Global Assessment score of 0 or 1 (sPGA success) vs 1.4% of patients who received placebo (P < .001).

The most common adverse events were arthralgia, nasopharyngitis, headache, and upper respiratory tract infection. Although cases of suicidal ideation and behavior were reported, no causal association between treatment with brodalumab and increased risk for suicidal ideation and behavior has been established, the companies note. Brodalumab's launch in Europe will be supported by postmarketing pharmacovigilance activities to capture and follow up any reports of safety events.

In the United States, brodalumab carries a boxed label warning concerning an observed risk for suicidal thoughts and actions. In addition, the drug is available only through a risk evaluation and mitigation strategy program.

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