FDA Gives AbbVie’s Skyrizi A Thumbs-Up For Plaque Psoriasis

Looking to fill an expected revenue hole when Humira’s patents end in 2023, AbbVie announced the U.S. Food and Drug Administration (FDA) had approved its Skyrizi (risankizumab-rzaa) for severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. They say the drug will be on the market in May.

Humira is AbbVie’s mega-blockbuster drug used to treat plaque psoriasis and a number of other immune diseases. In 2018, Humira brought in $19.94 billion. However, it will face biosimilar competition starting in 2023.

Plaque psoriasis is the most common type of psoriasis, caused by overproduction of skin cells. This causes inflamed, red lesions called plaques. They can be painful and itchy. It is the most common autoimmune disease in the U.S., affecting 7.5 million Americans.

In clinical trials, Skyrizi demonstrated high rates of durable skin clearing, with 82% and 81% of people receiving the drug reaching 90% skin clearance at one year, with 56% and 60% hitting complete skin clearance. The recommended dose is 150 mg administered via two subcutaneous injections every 12 weeks after two initial doses at weeks 0 and 4. It can be administered in the doctor’s office or, after training, be self-administered.

“The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals,” stated Kenneth B. Gordon, principal investigator for the ultima-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. “In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I’m pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response.”

Skyrizi is an interleukin-23 (IL-23) inhibitor. It selectively blocks IL-23 by binding to its p19 subunit. IL-23 is involved in inflammation and is thought to be associated to several chronic immune-mediated diseases, including psoriasis. The drug is approved in the U.S. and Canada for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is approved in Japan for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults who don’t respond adequately to conventional therapies.

Approval is expected for moderate to severe plaque psoriasis in the European Union this year. AbbVie also is evaluating Skyrizi in Phase III clinical trials in Crohn’s disease and psoriatic arthritis, as well as for ulcerative colitis.

At this time, AbbVie estimates that Skyrizi will have peak annual sales of $4 billion to $5 billion, although there will be intense competition. That’s also a long way from filling the holes caused by expected sales decreases of Humira.

AbbVie licensed the rights to Skyrizi from Boehringer Ingelheim for $595 million upfront in early 2016. In late 2017, the drug was tested against Johnson & Johnson’s Stelara and its own Humira in psoriasis and beat out both.

Other drugs in the market include Novartis’ Cosentyx, J&J’s Tremfya and Stelara, and Eli Lilly’s Taltz. Tremfya is, like Skyrizi, an IL-23 inhibitor. Tremfya is dosed every two months, while Skyrizi can be dosed once every three months.

Geoffrey Porges, an analyst with Leerink, in a note to investors, observed that other psoriasis biological, in addition to Celgene’s Otezla, which is an oral drug, created $11.1 billion in combined sales last year. “This does not include sales of anti-TNFs in psoriasis, which should decrease as patients move to these new, more efficacious therapies. These products also all achieved $500 million to $1 billion in the second year of launch, which is likely to also be achieved by Skyrizi. Overall biologics are still used in only 30% of the moderate to severe psoriasis population, (per JNJ in 2017), and AbbVie’s Skyrizi should benefit from both best-in-category efficacy (i.e. market share gains) and the continued rapid market expansion.” – Biospace