AbbVie gets crucial US approval for psoriasis drug Skyrizi

With one eye on life without its ageing $20 billion-a-year blockbuster Humira, AbbVie has got its psoriasis drug Skyrizi approved in the US.

Skyrizi is approved for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

AbbVie said the annual wholesale cost for maintenance dosing of Skyrizi is $59,000 per patient annually, adding that this is lower than its most widely-prescribed rivals.

The US pharma giant hopes that Skyrizi (risankizumab) will replace some of the sales lost as Humira faces competition from biosimilar near-copies over the coming years.

Humira is already off-patent and losing ground to rivals in Europe, although AbbVie’s legal defences have so far held fast in the US, preventing competition from biosimilars until 2023.

Although Humira is approved in a raft of different inflammatory disease indications, one of the most important of these is plaque psoriasis.

AbbVie hopes to get patients previously treated with Humira on to Skyrizi, an IL-23 inhibitor, thanks to clinical data showing it is more effective than its predecessor.

It has also tested Skyrizi against Johnson & Johnson’s competitor Stelara (ustekinumab) and hopes to compete on the basis of trial data showing it was more effective at stopping symptoms after a year.

Psoriasis is a notoriously competitive market, where Novartis’ Cosentyx (secukinumab) is fast gaining momentum, but the expectation is that Skyrizi will become a blockbuster several times over at peak sales.

The recommended dose for Skyrizi is 150 mg – administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and 4. It can be administered in-office or by self-injection after training.

Developed in partnership with Germany’s Boehringer Ingelheim, Skyrizi was approved in Japan and Canada in the past few weeks.

It also looks set for a launch in Europe later this year after the European Medicines Agency’s CHMP regulatory committee gave a positive opinion on Skyrizi in late March.

The decision has been passed on to the European Commission, which nearly always grants marketing authorisations within a few months of a ‘yes’ from the Committee for Medicinal Products for Human Use (CHMP).

Under the agreement with Boehringer, AbbVie will lead development and marketing globally.