FDA News

FDA approves Skyrizi for moderate to severe plaque psoriasis

AbbVie announced that the FDA has approved Skyrizi, an interleukin-23 inhibitor for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

The recommended dose for Skyrizi (risankizumab-rzaa) is 150 mg, administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and week 4, according to a company press release.

The interleukin-23 (IL-23) inhibitor selectively blocks IL-23 by binding to its p19 subunit.

The treatment may be administered in-office or by self-injection, according to the press release.

Four randomized, placebo and/or active-controlled studies assessed the treatment in adults with moderate to severe plaque psoriasis: ultlMMa-1, ultlMMa-2, IMMhance and IMMvent.

In ultlMMa-1 and ultlMM-2 at 16 weeks, Psoriasis Area and Severity Index (PASI) 90 was achieved in 75% of those treated with risankizumab-rzaa compared with 5% and 2% (P < .001) of patients receiving placebo, respectively, according to the press release.

In ultlMMa-1 and ultlMM-2, PASI 100 was achieved in 36% and 51% of patients treated with risankizumab-rzaa compared with 0% and 2% (P < .001) receiving placebo, respectively.

In the same studies at 1 year, 82% and 81% of people treated with risankizumab-rzaa achieved PSAI 90 (P < .001), respectively.

In patients treated with risankizumab-rzaa who achieved PASI 90 at week 16, 88% of patients maintained the response at 1 year. In those who achieved PASI 100 at week 16 with treatment, 80% of patients maintained the response at 1 year.

According to the release, the most common adverse events associated with the treatment include respiratory infection (13%), headaches (3.5%), fatigue (2.5%), injection site reactions (1.5%) and tinea infections (1.1%).

Skyrizi has also been approved in Japan and is currently under evaluation by the European Medicines Agency.

 

 

AbbVie announced that the FDA has approved Skyrizi, an interleukin-23 inhibitor for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

The recommended dose for Skyrizi (risankizumab-rzaa) is 150 mg, administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and week 4, according to a company press release.

The interleukin-23 (IL-23) inhibitor selectively blocks IL-23 by binding to its p19 subunit.

The treatment may be administered in-office or by self-injection, according to the press release.

Four randomized, placebo and/or active-controlled studies assessed the treatment in adults with moderate to severe plaque psoriasis: ultlMMa-1, ultlMMa-2, IMMhance and IMMvent.

In ultlMMa-1 and ultlMM-2 at 16 weeks, Psoriasis Area and Severity Index (PASI) 90 was achieved in 75% of those treated with risankizumab-rzaa compared with 5% and 2% (P < .001) of patients receiving placebo, respectively, according to the press release.

In ultlMMa-1 and ultlMM-2, PASI 100 was achieved in 36% and 51% of patients treated with risankizumab-rzaa compared with 0% and 2% (P < .001) receiving placebo, respectively.

In the same studies at 1 year, 82% and 81% of people treated with risankizumab-rzaa achieved PSAI 90 (P < .001), respectively.

In patients treated with risankizumab-rzaa who achieved PASI 90 at week 16, 88% of patients maintained the response at 1 year. In those who achieved PASI 100 at week 16 with treatment, 80% of patients maintained the response at 1 year.

According to the release, the most common adverse events associated with the treatment include respiratory infection (13%), headaches (3.5%), fatigue (2.5%), injection site reactions (1.5%) and tinea infections (1.1%).

Skyrizi has also been approved in Japan and is currently under evaluation by the European Medicines Agency.