Stelara ustekinumab regulatory update

The Scottish Medicines Consortium (SMC) recommended the restricted use of Stelara ustekinumab from Johnson & Johnson on the National Health Service (NHS) in Scotland to treat patients with active psoriatic arthritis who have failed on or are unsuitable for treatment with an anti- tumor necrosis factor (TNF) drug. Stelara is approved in the EU to treat active psoriatic arthritis alone or in combination with methotrexate in adult patients when the response to previous nonbiological DMARDs has been inadequate. In December, the U.K.'s NICE issued draft guidance recommending against Stelara to treat active psoriatic arthritis (see BioCentury, Jan. 6). The human mAb inhibiting IL-12 and IL-23 is approved in the U.S. to treat active psoriatic arthritis in adults as monotherapy or in combination with methotrexate. ...