FDA lengths review of Skyrizi for Crohn’s

AbbVie (NYSE:ABBV) has announced that the FDA will prolong the review period for Skyrizi (risankizumab-rzaa) to treat moderate to severe Crohn’s disease in patients 16 years and older.

The agency decided to extend the Prescription Drug User Fee Act (PDUFA) action date for the indication by three months to review additional data submitted from the sponsor related in part to an on-body injector.

FDA first approved Skyrizi, an interleukin-23 subunit p19 inhibitor, for moderate to severe plaque psoriasis in adults. Then, in January, it won an indication for adults with active psoriatic arthritis.

AbbVie developed the drug in partnership with Boehringer Ingelheim.

Last year, sales of the drug were $2.939 billion internationally.

AbbVie has also filed an application with the European Medicines Agency asking for approval of Skyrizi to treat patients at least 16 years with moderate to severe Crohn’s disease.

ABBV shares ticked do…

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Janssen presents new safety data for Stelara in older patients

Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials.

The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from 13 clinical trials across approved indications, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The analysis included data for up to five years.

“This particular analysis builds on the complete data we have on the safety of Stelara over thousands of patients and literally dozens of clinical trials over 20 years now,” said Dr. Andrew Greenspan, vice president of medical affairs at Janssen Immunology.

The analysis is also noteworthy in its focus on patients 60 and older, Greenspan said.

“Often, we limit patients who are older from the clinical trials, and that’s not …

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Phase 3 Tremfya results are promising for plaque psoriasis and psoriatic arthritis

Johnson & Johnson’s (NYSE:JNJ) pharmaceutical subsidiary Janssen has announced that its Tremfya (guselkumab) selective interleukin (IL)-23 inhibitor therapy led to durable, complete skin clearance in the majority of adults with moderate-to-severe plaque psoriasis (PsO) for up to five years. The drug also showed substantial efficacy in treating active psoriatic arthritis (PsA) for up to one year.

A total of 55% of patients receiving Tremfya had complete skin clearance, while 85% had an Investigator’s Global Assessment (IGA) score of either 0 or 1 at week 252 in the Phase 3 trial. IGA is a five-point system for characterizing psoriasis severity. A score of zero indicates complete clearing, while a score of one is for “almost clear” skin.

With 2020 sales hitting $1.35 billion, Tremfya is the only interleukin (IL)-23 inhibitor that is FDA approved for both moderate-to-severe plaque psoriasis and psoriatic arthritis.

Janssen had concluded earlier that sev…

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