![]() The Novartis division intends to market the drug in the United States from July 1, 2023. In March 2023, Novartis (through its Sandoz division) announced that the FDA had approved its Humira biosimilar, which will be marketed under the trade name Hyrimoz. Like Amgen, several other companies like Biogen, Boehringer Ingelheim and Pfizer have also received FDA approvals for their own Humira biosimilars, many of which are expected to be launched at various times this year per agreements with AbbVie. The biosimilar is being marketed by Amgen under the trade name Amjevita. In January, Amgen announced the launch of the first Humira biosimilar in the United States. Companies like Amgen, Novartis and Biogen were the first to start commercializing a Humira-biosimilar in Europe in 2018. Humira’s international sales are already eroding due to the launch of several direct biosimilar drugs in Europe by other pharma companies, including Amgen ( AMGN Quick Quote AMGN - Free Report), Novartis’ ( NVS Quick Quote NVS - Free Report) Sandoz division and Biogen. Over the years, AbbVie’s Humira sales have been steadily declining due to biosimilars eroding the ex-U.S. Both Skyrizi and Rinvoq demonstrated differentiated clinical profiles, compared to Humira. Apart from CD, Rinvoq is also approved for rheumatoid arthritis, PsA, UC, ankylosing spondylitis and eczema indications.ĪbbVie is focused on strengthening its focus on new immunology medicines, Skyrizi and Rinvoq, to lessen its dependence on Humira, a major top-line driver for AbbVie, which recently lost exclusivity in the United States. The approval marks the seventh FDA-approved indication for Rinvoq across rheumatology, dermatology and gastroenterology. ![]() Last month, the FDA approved AbbVie’s blockbuster JAK inhibitor Rinvoq for the treatment of adults with moderately to severely active CD who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. During first-quarter 2023, J&J recorded revenues worth $2.4 billion from Stelara sales. Evidently, Stelara is one of J&J’s top-line drivers. The drug is also approved for other indications, including psoriasis, CD and PsA. ![]() AbbVie faces stiff competition from Johnson & Johnson ( JNJ Quick Quote JNJ - Free Report), which markets its own drug Stelara which utilizes a similar mechanism of action to treat the CD indication.Ī blockbuster drug, J&J’s Stelara is a human IL-12 and IL-23 antagonist approved by the FDA for treating moderately to severely active UC. The targeted UC market is highly competitive. In March, AbbVie reported top-line data from the INSPIRE study, wherein treatment with an intravenous 1200mg dose of Skyrizi achieved the primary endpoint of clinical remission at week 12. ![]() The COMMAND study enrolled only those patients who had responded to induction treatment with the drug in the phase III INSPIRE study. Shares of AbbVie have declined 15.9% so far this year against the industry’s 0.6% rise. The drug’s safety profile was consistent with the data from prior studies in other indications.Ĭurrently, Skyrizi is approved by the FDA for three indications, which are plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (“CD”). Study participants who were administered Skyrizi also achieved endoscopic improvement, histologic-endoscopic mucosal improvement and steroid-free remission following 52 weeks of treatment, which were also the study’s key secondary endpoints. ( ABBV Quick Quote ABBV - Free Report) announced top-line data from the phase III maintenance study, COMMAND, which evaluated its IL-23 drug Skyrizi (risankizumab) in adult patients with moderately to severely active ulcerative colitis (“UC”) indication.ĭata from the COMMAND study showed that a significantly higher proportion of patients treated with Skyrizi (180mg or 360mg, administered subcutaneously) achieved the primary endpoint of clinical remission at week 52.40% and 38% of study participants who received the 180mg and 360mg dose of the drug, respectively, achieved clinical remission, compared to 25% of patients enrolled in the control group. ![]()
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