Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance

A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]

The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.

The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…

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AbbVie’s Skyrizi becomes first drug to win FDA nod for Crohn’s disease

AbbVie (NYSE:ABBV) has announced that FDA has approved Skyrizi (risankizumab-rzaa) as the first interleukin-23 (IL-23) inhibitor to treat adults with moderately to severely active Crohn’s disease (CD).

Skyrizi is also FDA-approved as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis.

IL-23 inhibitors have surged in popularity recently, given their ability to treat diseases such as plaque psoriasis.

Janssen’s Stelara (ustekinumab), which inhibits both IL-12 and IL-23, has racked up the most indications. It is now FDA-approved for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Stelara was first FDA-approved in 2009.

Skyrizi is a newer drug, winning FDA approval for plaque psoriasis in 2019.

A 2019 analysis found that Skyrizi had higher efficacy than placebo and Stelara in treating moderate-to-severe chronic plaque psoriasis.

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AbbVie’s Rinvoq supports clinical remission in Phase 3 Crohn’s disease study

AbbVie (NYSE:ABBV) has revealed positive topline results from the U-ENDURE Phase 3 study investigating 15- and 30-mg doses of Rinvoq (upadacitinib) in adults with moderate to severe Crohn’s disease.

Recipients who received either dose met the co-primary endpoints of endoscopic response and clinical remission, AbbVie announced. More than one-third (36%) of participants who received 15 mg of upadacitinib achieved clinical remission at week 52. A total of 46% of those receiving the 30-mg dose achieved the same benchmark, compared with 14% of placebo recipients.

Subjects also achieved the secondary endpoint of endoscopic remission at 52 weeks compared to placebo.

Study participants were poor candidates for conventional or biologic therapy.

The study defined clinical remission using the Crohn’s Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).

Rinvoq first won FDA approval in 2019 for rheumatoid ar…

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Janssen’s pathway strategy for immune-mediated inflammatory disease shows promise in gastroenterology

Tens of millions of Americans have immune-mediated inflammatory diseases (IMIDs), including conditions as diverse as rheumatoid arthritis, psoriasis, multiple sclerosis and inflammatory bowel disease.

Because such diseases have an inflammatory component, a single biologic could treat multiple IMIDs. “We are committed to investigating inflammatory pathways to develop therapies that can potentially address the immense unmet need for patients living with immune-mediated diseases,” said Dr. Jan Wehkamp, Janssen’s vice president, gastroenterology disease area leader.

And thus, a drug like Janssen’s Tremfya (guselkumab), which is now indicated to treat moderate-to-severe plaque psoriasis and psoriatic arthritis in adults, could find use in gastroenterological conditions such as Crohn’s disease (CD) or ulcerative colitis (UC).

Tremfya selectively blocks the p19 subunit of interleukin (IL)-23.

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Rinvoq meets primary and important secondary endpoints in Phase 3 Crohn’s disease study

AbbVie (NYSE:ABBV) has released positive top-line results from U-EXCEED, which showed that Rinvoq (upadacitinib) hit both primary endpoints of clinical remission and endoscopic response at week 12 of a Phase 3 induction study focused on patients with Crohn’s disease.

Upadacitinib is a selective and reversible JAK inhibitor first FDA approved in 2019 for treating adults with moderate to severe rheumatoid arthritis. It is now also marketed for ankylosing spondylitis and psoriatic arthritis.

The U-EXCEED is the first of two Phase 3 induction studies testing upadacitinib in adults with moderate to severe Crohn’s disease.

The multicenter study was randomized, double-blind and placebo-controlled.

Image courtesy of AbbVie

The patients in the U-EXCEED enrolled patients with Crohn’s disease who had a poor response or were intolerant to biologics. In the patient pool, more than 60% had failed two …

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Janssen shares positive Phase 2 Tremfya data in Crohn’s

Johnson & Johnson’s Janssen division (NYSE:JNJ) has released topline results from the Phase 2 GALAXI 1 clinical study testing the potential of TREMFYA (guselkumab) in patients with moderately to severely active Crohn’s disease (CD).

The study found that nearly two-thirds (65%) of TREMFYA (guselkumab) recipients achieved clinical remission at week 48. The trial used the Crohn’s Disease Activity Index [CDAI]<150) to verify that benchmark.

The study provided the first long-term data testing guselkumab as a potential CD treatment in the U.S.

Guslkumab selectively inhibits the p19 subunit of interleukin IL-23.

Guselkumab is now FDA approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis, but not yet for Crohn’s disease.

Tremfya (guselkumab) won FDA approval for adult patients with active psoriatic arthritis in 2020.

The placebo-controlled double-blind stu…

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Janssen shares new positive Stelara data for Crohn’s disease and ulcerative colitis

Janssen (NYSE:JNJ) has released new positive data for Stelara (ustekinumab) as first-line therapy in ulcerative colitis (UC) and treatment persistence in Crohn’s disease (CD).

The data indicated that the monoclonal antibody Stelara was “the best choice” as a “first-line therapy in bio-naive patients with moderately to severely active ulcerative colitis and Crohn’s disease,” said Dr. Jan Wehkamp, vice president, gastroenterology disease area leader, Janssen Research & Development, in an interview.

In a separate analysis, Stelara led to more persistent therapeutic effects than Humira (adalimumab) at 12 months in bio-naive CD patients. Janssen gathered the CD data from de-identified health insurance claims.

Janssen presented the data, based on new modeling and real-world evidence analyses, at the American College of Gastroenterology Annual Scientific Meeting (ACG).

First-line Stelara patients with moderately to severely active UC tended to have a…

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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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Scientists identify new strategy for treating inflammatory bowel diseases

Scientists at the Ben-Gurion University of the Negev (BGU) in Israel and Yonsei University in Seoul have identified a potential strategy to treat inflammatory bowel diseases (IBD). The method involves using peptides to reduce the effects of succinate, a proinflammatory molecule that gut bacteria release. The breakthrough could lead to a companion tool to diagnose and treat inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.

The gut levels of succinate are considerably higher in macrophages of IBD patients, according to BGU professor Ehud Ohana. Furthermore, IBD patients have altered succinate-metabolizing bacteria that likely results in inflammation-inducing succinate surges. The international research team reported slowing succinate absorption by deploying peptide sequences that mimic the binding site within succinate binding enzymes.

The researchers developed a method of targeting and chelating surplus succinate in IBD patients. To do …

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